35 results on '"Jan L. Shifren"'
Search Results
2. Improving the identification of genitourinary syndrome of menopause through the utilization of the Day-to-Day Impact of Vaginal Aging questionnaire
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Jan L. Shifren, Andrea Zuckerman, Julie Thompson, Katherine Pereira, and Jennie Mastroianni
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Aging ,Chronic condition ,medicine.medical_specialty ,business.industry ,Genitourinary system ,Obstetrics ,Applied Mathematics ,General Mathematics ,Significant difference ,MEDLINE ,Obstetrics and Gynecology ,medicine.disease ,Postmenopause ,Diva ,Menopause ,Surveys and Questionnaires ,Vagina ,Humans ,Medicine ,Female ,In patient ,Atrophy ,Day to day ,business - Abstract
Genitourinary syndrome of menopause (GSM) affects nearly 50% of postmenopausal women. Yet women fail to recognize GSM as a chronic condition and are reluctant to discuss their vaginal or sexual complaints with a health care provider. This quality improvement project implemented the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire to improve the identification and diagnosis of GSM in women ≥ 45 years of age presenting for an annual wellness examination or a vulvovaginal/genitourinary complaint.From October 2019 to February 2020, the DIVA questionnaire was distributed in a large women's health practice setting to women ≥ 45 years of age, for completion before their annual wellness visit or for evaluation of a GSM-related complaint. GSM diagnosis rates during the implementation period were compared with diagnosis rates during a 4-month period immediately preceding the implementation. Data collected during the implementation period were examined to evaluate if GSM diagnosis was more likely in patients who completed the DIVA questionnaire when compared to those women who did not complete the questionnaire.Of the 175 women who met the inclusion criteria, 113 completed the DIVA questionnaire. Completion of the DIVA questionnaire demonstrated a relative percentage increase in GSM diagnosis by 30.7% when compared to the 4-month preimplementation period (10.1% to 13.2%, P = 0.231). This change was not statistically significant. During the implementation period, a statistically significant difference in GSM diagnosis was observed for patients who completed the DIVA questionnaire when compared to those patients who did not complete the questionnaire (37.2% vs 9.7%, P 0.001). When results were stratified by visit type, women presenting for an annual wellness visit who completed the DIVA questionnaire had a higher GSM diagnosis rate than those who did not complete the questionnaire (37.2% vs 10%, P 0.001). When results were stratified by menopausal status, GSM diagnosis rates were also more likely for postmenopausal women who completed the DIVA questionnaire when compared to those who did not complete the questionnaire (44.2% vs 8.5%, P 0.001).The DIVA questionnaire is a brief, but comprehensive screening tool that can increase GSM identification and treatment, particularly for postmenopausal, and midlife women presenting for an annual wellness visit in a busy women's health practice setting. : Video Summary:http://links.lww.com/MENO/A655.Video Summary:http://links.lww.com/MENO/A655.
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- 2020
3. The National Academies of Science, Engineering, and Medicine (NASEM) Report on Compounded Bioidentical Hormone Therapy
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Jan L. Shifren, JoAnn V. Pinkerton, James H. Liu, JoAnn E. Manson, Nanette Santoro, Cynthia A. Stuenkel, Andrew M. Kaunitz, and Stephanie S. Faubion
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Hormone Replacement Therapy ,business.industry ,medicine.medical_treatment ,Estrogen Replacement Therapy ,MEDLINE ,Obstetrics and Gynecology ,medicine.disease ,Bioinformatics ,Hormones ,Menopause ,Humans ,Medicine ,Female ,Hormone therapy ,Hormone replacement therapy ,Estrogen replacement therapy ,business ,Hormone - Published
- 2020
4. Women's experience of vulvovaginal symptoms associated with menopause
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Ellen L Cho, Michael Krychman, Rebekah Zincavage, Ashley M. Magnavita, David Portman, Jan L. Shifren, Raymond C. Rosen, James A. Simon, and Sheryl A. Kingsberg
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Activities of daily living ,Prom ,Vulva ,Quality of life ,Surveys and Questionnaires ,Humans ,Medicine ,Patient Reported Outcome Measures ,Sexual Dysfunctions, Psychological ,Pelvic examination ,medicine.diagnostic_test ,business.industry ,Debriefing ,Obstetrics and Gynecology ,Middle Aged ,Cognitive test ,Sexual Dysfunction, Physiological ,Sexual dysfunction ,Vagina ,Quality of Life ,Female ,Atrophy ,Menopause ,medicine.symptom ,business ,Sexual function ,Clinical psychology - Abstract
Objective This study describes women's experiences of the genitourinary syndrome of menopause (GSM) elicited through focus groups and cognitive debriefing sessions during development of a novel patient-reported outcome measure (PROM) designed for use in both clinical care and research. Methods A draft questionnaire to identify and assess bothersome genitourinary symptoms associated with estrogen deficiency in menopausal women was developed in five discrete phases from multiple sources of information in accordance with standards for PROM development. GSM was confirmed by report of symptoms in conjunction with a confirmatory pelvic examination and laboratory assessments. Results Qualitative content interviews were completed in 36 menopausal women with GSM. Cognitive testing of draft PROM items was performed in nine focus groups, including 26 menopausal women with and 15 without GSM. Participants reported a range of symptoms and described associated impacts on more than 15 quality-of-life domains. The majority of women reported that their symptoms impacted their sexual functioning and had a negative effect on their overall quality of life. GSM affected many aspects of menopausal women's lives beyond sexual function, with descriptions of pain when walking, urinating, wearing tight clothes, and with other activities of daily living. Conclusions Women's own words methodically recorded and analyzed during qualitative interviews and cognitive debriefing focus groups illuminate the subjective experience of women with GSM. It is hoped that the PROM currently in development will provide an effective tool for increasing our understanding of the prevalence, predictors, and impact of GSM in menopausal women's lives.
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- 2019
5. Vaginal estrogen use and chronic disease risk in the Nurses’ Health Study
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JoAnn E. Manson, Walter C. Willett, Francine Grodstein, Carolyn J. Crandall, Meir J. Stampfer, Shilpa N Bhupathiraju, and Jan L. Shifren
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medicine.medical_specialty ,General Mathematics ,Deep vein ,Myocardial Infarction ,Nurses ,Breast Neoplasms ,030209 endocrinology & metabolism ,Disease ,Article ,Vaginal estrogen ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Surveys and Questionnaires ,Internal medicine ,medicine ,Humans ,Longitudinal Studies ,Prospective Studies ,Stroke ,Estrogens, Conjugated (USP) ,030219 obstetrics & reproductive medicine ,business.industry ,Applied Mathematics ,Estrogen Replacement Therapy ,Obstetrics and Gynecology ,Cancer ,Middle Aged ,medicine.disease ,Thrombosis ,United States ,Menopause ,Administration, Intravaginal ,medicine.anatomical_structure ,Chronic Disease ,Female ,Nurses' Health Study ,business - Abstract
OBJECTIVE: To examine the associations between vaginal estrogen use and multiple health outcomes including cardiovascular disease (total myocardial infarction, stroke, and pulmonary embolism/deep vein thrombosis), cancer (total invasive, breast, endometrial, ovarian, and colorectal cancer), and hip fracture. METHODS: We included postmenopausal women from the Nurses’ Health Study (1982–2012) who were not current users of systemic hormone therapy at the start of the study or during follow-up. Vaginal estrogen use was self-reported on the biennial questionnaires. Information on incident health outcomes were self-reported and confirmed by medical records. We used Cox proportional hazards regression to model the multivariable adjusted hazard ratios and the 95% confidence intervals for vaginal estrogen use and multiple health outcomes. RESULTS: Over 18 years of follow-up, after adjusting for covariates, risks for cardiovascular disease, cancer, and hip fracture were not different between users and non-users of vaginal estrogen. No statistically significant increase in risk of any health outcome was observed with vaginal estrogen use. In sensitivity analyses, when we examined associations by hysterectomy status, the stratified results were generally similar to those for the total cohort. CONCLUSIONS: Vaginal estrogen use was not associated with a higher risk of cardiovascular disease or cancer. Our findings lend support to the safety of vaginal estrogen use, a highly effective treatment for genitourinary syndrome of menopause.
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- 2018
6. Genitourinary Syndrome of Menopause
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Jan L. Shifren
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Selective Estrogen Receptor Modulators ,medicine.medical_specialty ,Labia ,Administration, Oral ,Clitoris ,Introitus ,Vaginal estrogen ,Vulva ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Lower Urinary Tract Symptoms ,Ospemifene ,medicine ,Humans ,Physical Therapy Modalities ,Lubricants ,030219 obstetrics & reproductive medicine ,Obstetrics ,business.industry ,Genitourinary system ,Obstetrics and Gynecology ,Estrogens ,Dehydroepiandrosterone ,medicine.disease ,Menopause ,Administration, Intravaginal ,Tamoxifen ,Dyspareunia ,medicine.anatomical_structure ,chemistry ,030220 oncology & carcinogenesis ,Vagina ,Female ,Laser Therapy ,Atrophy ,business - Abstract
Genitourinary syndrome of menopause (GSM) describes a collection of exam findings and bothersome symptoms associated with estrogen deficiency involving changes to the labia, introitus, clitoris, vagina, urethra, and bladder. Vulvovaginal atrophy is a component of GSM. GSM is a highly prevalent medical condition with adverse effects on the health and quality of life of midlife women. There are many effective treatment options, including nonhormonal lubricants and moisturizers, physical therapy, low-dose vaginal estrogen therapy, vaginal dehydroepiandrosterone, and oral ospemifene. Despite the availability of safe and effective therapies, GSM often remains unrecognized and untreated.
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- 2018
7. The 2017 hormone therapy position statement of The North American Menopause Society
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Lawrence M. Nelson, Susan Hoffstetter, Polly Marchbanks, Felicia Cosman, Robert L. Reid, JoAnn E. Manson, Fernando Sánchez Aguirre, Cynthia A. Stuenkel, Jennifer Blake, JoAnn V. Pinkerton, Andrew M. Kaunitz, Phillip M. Sarrel, Wulf H. Utian, Sheryl A. Kingsberg, Lila E. Nachtigall, Pauline M. Maki, Howard N. Hodis, Diane Todd Pace, Michael R. McClung, and Jan L. Shifren
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medicine.medical_specialty ,Time Factors ,General Mathematics ,medicine.medical_treatment ,Reproductive medicine ,European Menopause and Andropause Society ,Risk Assessment ,Vaginal estrogen ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Risk Factors ,medicine ,Humans ,030212 general & internal medicine ,Osteoporosis, Postmenopausal ,Societies, Medical ,Aged ,Reproductive health ,030219 obstetrics & reproductive medicine ,business.industry ,Applied Mathematics ,Estrogen Replacement Therapy ,Obstetrics and Gynecology ,Estrogens ,Middle Aged ,medicine.disease ,Vasomotor System ,Menopause ,Family medicine ,North America ,Female ,Vaginal atrophy ,Hormone therapy ,Progestins ,business - Abstract
The 2017 Hormone Therapy Position Statement of The North American Menopause Society (NAMS) updates the 2012 Hormone Therapy Position Statement of The North American Menopause Society and identifies future research needs. An Advisory Panel of clinicians and researchers expert in the field of women's health and menopause was recruited by NAMS to review the 2012 Position Statement, evaluate new literature, assess the evidence, and reach consensus on recommendations, using the level of evidence to identify the strength of recommendations and the quality of the evidence. The Panel's recommendations were reviewed and approved by the NAMS Board of Trustees. Hormone therapy (HT) remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture. The risks of HT differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used. Treatment should be individualized to identify the most appropriate HT type, dose, formulation, route of administration, and duration of use, using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation of the benefits and risks of continuing or discontinuing HT. For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio is most favorable for treatment of bothersome VMS and for those at elevated risk for bone loss or fracture. For women who initiate HT more than 10 or 20 years from menopause onset or are aged 60 years or older, the benefit-risk ratio appears less favorable because of the greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia. Longer durations of therapy should be for documented indications such as persistent VMS or bone loss, with shared decision making and periodic reevaluation. For bothersome GSM symptoms not relieved with over-the-counter therapies and without indications for use of systemic HT, low-dose vaginal estrogen therapy or other therapies are recommended. This NAMS position statement has been endorsed by Academy of Women's Health, American Association of Clinical Endocrinologists, American Association of Nurse Practitioners, American Medical Women's Association, American Society for Reproductive Medicine, Asociación Mexicana para el Estudio del Climaterio, Association of Reproductive Health Professionals, Australasian Menopause Society, Chinese Menopause Society, Colegio Mexicano de Especialistas en Ginecologia y Obstetricia, Czech Menopause and Andropause Society, Dominican Menopause Society, European Menopause and Andropause Society, German Menopause Society, Groupe d’études de la ménopause et du vieillissement Hormonal, HealthyWomen, Indian Menopause Society, International Menopause Society, International Osteoporosis Foundation, International Society for the Study of Women's Sexual Health, Israeli Menopause Society, Japan Society of Menopause and Women's Health, Korean Society of Menopause, Menopause Research Society of Singapore, National Association of Nurse Practitioners in Women's Health, SOBRAC and FEBRASGO, SIGMA Canadian Menopause Society, Società Italiana della Menopausa, Society of Obstetricians and Gynaecologists of Canada, South African Menopause Society, Taiwanese Menopause Society, and the Thai Menopause Society. The American College of Obstetricians and Gynecologists supports the value of this clinical document as an educational tool, June 2017. The British Menopause Society supports this Position Statement.
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- 2017
8. Menopausal Hormone Therapy
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Carolyn J. Crandall, Jan L. Shifren, and JoAnn E. Manson
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Oncology ,medicine.medical_specialty ,business.industry ,Estrogen Replacement Therapy ,MEDLINE ,Endocrine therapy ,Sweating ,General Medicine ,medicine.disease ,Risk Assessment ,Menopause ,Quality of life ,Internal medicine ,Hot Flashes ,medicine ,Quality of Life ,Humans ,Female ,Menopausal hormone therapy ,Estrogen replacement therapy ,Risk assessment ,business - Published
- 2019
9. Use of compounded hormone therapy in the United States
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Andrea Z. LaCroix, Cynthia A. Stuenkel, Jan L. Shifren, Wulf H. Utian, James H. Liu, and Margery Gass
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Adult ,medicine.medical_specialty ,Hormone Replacement Therapy ,medicine.medical_treatment ,MEDLINE ,Food and drug administration ,Risk Factors ,Surveys and Questionnaires ,medicine ,Humans ,Testosterone ,Estrogen replacement therapy ,Aged ,Aged, 80 and over ,Gynecology ,United States Food and Drug Administration ,business.industry ,Estrogen Replacement Therapy ,Age Factors ,Obstetrics and Gynecology ,Testosterone (patch) ,Middle Aged ,medicine.disease ,United States ,Endometrial Neoplasms ,Postmenopause ,Menopause ,Transgender hormone therapy ,Family medicine ,Income ,Educational Status ,Female ,Hormone therapy ,business - Abstract
A national survey was conducted to determine the extent of use of compounded hormone therapy (C-HT) and to characterize the differences between C-HT users and users of hormone therapy approved by the US Food and Drug Administration (FDA-HT users).This Internet survey enrolled 3,725 women aged 40 to 84 years who were postmenopausal or experiencing the menopause transition. The sample was weighted slightly by age, region, education, and race to reflect population attributes based on US Census data.Overall, 9% of women were current users of HT, and 28% of all respondents were ever-users of HT. C-HT users represented 31% of ever-users of HT, 35% of current users of HT, and 41% of ever-users aged 40 to 49 years. Approximately 13% of ever-users indicated current or past use of testosterone. The most cited reason for using HT was vasomotor symptoms (∼70%). Nonapproved indications for using HT were selected more often by C-HT users. There were four reports of endometrial cancer among the 326 C-HT users compared with none reported among the 738 FDA-HT users. Significance was not determined because of small numbers.This survey indicates substantial use of C-HT across the country and the possibility of higher rates of endometrial side effects with such products. There is a need for standardized data collection on the extent of use of compounded hormones and their potential risks.
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- 2015
10. Association between HIV status and psychological symptoms in perimenopausal women
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Hadine Joffe, Jan L. Shifren, Laura M. Smeaton, Sara E. Looby, Corinne Rivard, Steven K. Grinspoon, Christina Psaros, and Greer A Raggio
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Longitudinal study ,medicine.medical_specialty ,Cross-sectional study ,Population ,HIV Infections ,Article ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Interquartile range ,Internal medicine ,Antiretroviral Therapy, Highly Active ,Medicine ,Humans ,030212 general & internal medicine ,Longitudinal Studies ,Prospective Studies ,education ,education.field_of_study ,Depressive Disorder ,030219 obstetrics & reproductive medicine ,business.industry ,Obstetrics and Gynecology ,Center for Epidemiologic Studies Depression Scale ,Middle Aged ,medicine.disease ,United States ,Perimenopause ,Menopause ,Cross-Sectional Studies ,Hot Flashes ,Quality of Life ,Anxiety ,Patient Compliance ,Female ,medicine.symptom ,business - Abstract
Objective HIV-infected women are burdened by depression and anxiety, which may impact adherence to antiretroviral therapy and overall quality of life. Yet, little is known about the scope of psychological symptoms in the growing number of HIV-infected women reaching menopause, when affective symptoms are more prevalent in the general population. We conducted a longitudinal study to compare affective symptoms between perimenopausal HIV-infected and non-HIV-infected women. Methods The Center for Epidemiologic Studies Depression Scale (CES-D), and the Generalized Anxiety Disorder scale (GAD-7) were completed at baseline and 12 months among 33 HIV-infected and 33 non-HIV-infected perimenopausal women matched by race, age, menstrual patterns, and BMI. Linear regression models estimated the relationship of baseline GAD-7 and CES-D scores with clinical factors. Results All women were perimenopausal at baseline, and the vast majority remained perimenopausal throughout follow-up. HIV status was associated with higher baseline CES-D scores (median [interquartile range] 21 [12, 29] vs 10 [5, 14]; P = 0.03) and GAD-7 scores (7 [5, 15] vs 2 [1, 7]; P = 0.01), controlling for smoking, substance use, and antidepressant use. Depressive symptoms and anxiety remained significantly higher in the HIV-infected women at 12 months (P ≤ 0.01). Significant relationships of depressive symptoms (P = 0.048) and anxiety (P = 0.02) with hot flash severity were also observed. Conclusions Perimenopausal HIV-infected women experienced a disproportionately high level of affective symptom burden over a 12-month observation period. Given the potential for these factors to influence adherence to HIV clinical care and quality of life, careful assessment and referral for treatment of these symptoms is essential.
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- 2018
11. Effects of estrogen and venlafaxine on menopause-related quality of life in healthy postmenopausal women with hot flashes
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Susan D. Reed, Joseph C. Larson, Andrea Z. LaCroix, Barbara Sternfeld, Kristine E. Ensrud, JoAnn E. Manson, Lee S. Cohen, Kathy Rexrode, Katherine M. Newton, Katherine A. Guthrie, Jan L. Shifren, Hadine Joffe, Bette J. Caan, Ellen W. Freeman, and Janet S. Carpenter
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Adult ,medicine.medical_specialty ,medicine.drug_class ,Treatment outcome ,Venlafaxine ,Placebo ,law.invention ,Dose-Response Relationship ,Double-Blind Method ,Randomized controlled trial ,Quality of life ,law ,Internal medicine ,medicine ,Humans ,Obstetrics & Reproductive Medicine ,Gynecology ,Medical And Health Sciences ,Postmenopausal women ,Estradiol ,Dose-Response Relationship, Drug ,business.industry ,Estrogen Replacement Therapy ,Venlafaxine Hydrochloride ,Obstetrics and Gynecology ,Middle Aged ,medicine.disease ,Postmenopause ,Menopause ,Treatment Outcome ,Estrogen ,Hot Flashes ,Serotonin Uptake Inhibitors ,Quality of Life ,Female ,Drug ,business ,Selective Serotonin Reuptake Inhibitors ,medicine.drug - Abstract
ObjectiveThis study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes.MethodsA double-blind, placebo-controlled, randomized trial of low-dose oral 17β-E2 0.5 mg/day and venlafaxine XR 75 mg/day, versus identical placebo, was conducted among 339 women (aged 40-62 y) experiencing two or more vasomotor symptoms (VMS) per day (mean [SD], 8.07 [5.29]) who were recruited at three clinical sites from November 2011 to October 2012. The primary trial outcome, as reported previously, was frequency of VMS at 8 weeks. Here, we report on secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and from measures of pain (Pain, Enjoyment in life, and General activity scale), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder Questionnaire-7), and perceived stress (Perceived Stress Scale).ResultsTreatment with both E2 and venlafaxine resulted in significantly greater improvement in quality of life, as measured by total MENQOL scores, compared with placebo (E2: mean difference at 8 wk, -0.4; 95% CI, -0.7 to -0.2; P < 0.001; venlafaxine: mean difference at 8 wk, -0.2; 95% CI, -0.5 to 0.0; P = 0.04). Quality-of-life domain analyses revealed that E2 had beneficial treatment effects on all domains of the MENQOL except for the psychosocial domain, whereas venlafaxine benefits were observed only in the psychosocial domain. Neither E2 nor venlafaxine improved pain, anxiety, or depressive symptoms, although baseline symptom levels were low. Modest benefits were observed for perceived stress with venlafaxine.ConclusionsBoth low-dose E2 and venlafaxine are effective pharmacologic agents for improving menopause-related quality of life in healthy women with VMS.
- Published
- 2015
12. Algorithm and mobile app for menopausal symptom management and hormonal/non-hormonal therapy decision making
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Margery Gass, JoAnn E. Manson, Isaac Schiff, Andrew M. Kaunitz, Diane Todd Pace, Jeff Ames, JoAnn V. Pinkerton, Risa Kagan, Jan L. Shifren, Hadine Joffe, Steven R. Goldstein, Cynthia A. Stuenkel, Marla Shapiro, James H. Liu, Sheryl A. Kingsberg, Peter F. Schnatz, Gloria Richard-Davis, and Wulf H. Utian
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medicine.medical_specialty ,business.industry ,Non hormonal ,Decision Making ,Estrogen Replacement Therapy ,Mobile apps ,Obstetrics and Gynecology ,medicine.disease ,Mobile Applications ,Clinical decision support system ,Menopause ,medicine ,Physical therapy ,Humans ,Menopausal Symptom ,Female ,business ,Algorithms ,Decision Making, Computer-Assisted ,Societies, Medical ,Hormone - Published
- 2015
13. Increased hot flash severity and related interference in perimenopausal human immunodeficiency virus–infected women
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Steven K. Grinspoon, Maria C. Pedersen, Alison M. Rope, Hadine Joffe, Jan L. Shifren, Inge B. Corless, and Sara E. Looby
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Gynecology ,medicine.medical_specialty ,education.field_of_study ,genetic structures ,Extramural ,business.industry ,Daily function ,Population ,Human immunodeficiency virus (HIV) ,virus diseases ,Obstetrics and Gynecology ,Physiology ,medicine.disease ,medicine.disease_cause ,Menopause ,Mood ,Quality of life ,Hot flash ,medicine ,medicine.symptom ,education ,business - Abstract
Objective As women with HIV are living longer, more are entering the perimenopause. Prior studies suggest that HIV-infected women are more likely to have hot flashes than non-HIV-infected women. However, little is known regarding the severity and degree of interference that hot flashes have on daily function, mood, and quality of life in this population.
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- 2014
14. Endocrine Aspects of Women's Sexual Function
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Jan L. Shifren, Willam Rosner, Nancy E. Avis, Susan R. Davis, Margaret E. Wierman, Rossella E. Nappi, and Ferdinand Labrie
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medicine.medical_specialty ,Urology ,Endocrinology, Diabetes and Metabolism ,Female sexual dysfunction ,Diabetes Complications ,Endocrinology ,Endocrine Glands ,Sexual medicine ,medicine ,Humans ,Endocrine system ,Testosterone ,Gynecology ,Estrogens ,Testosterone (patch) ,medicine.disease ,Menopause ,Sexual Dysfunction, Physiological ,Psychiatry and Mental health ,Sexual dysfunction ,Reproductive Medicine ,Female ,medicine.symptom ,Psychology ,Sexual function ,Polycystic Ovary Syndrome ,Clinical psychology ,Hormone - Abstract
Introduction. Endocrine changes during aging as well as endocrine disorders may either directly or indirectly modulate female sexual function by altering sex hormones, or by impacting on vascular, neurogenic, or psychologic factors. Aim. To review information on the impact of the hormonal changes associated with aging or those caused by endocrine disorders on female sexual function and current information on the risks and benefits of hormonal treatments. Methods. Committee members outlined topics and reviewed the published literature on endocrine aspects of female sexual function over a 2-year period. Presentation of the recommendations were presented at the International Consultation on Sexual Medicine Paris, France 2009 and revised accordingly. Main Outcome Measures. Quality of data published in the literature and recommendations were based on the GRADES system. Results. Recommendations and guidelines concerning the role of sex hormones and endocrine disorders in female sexual function were derived. Conclusions. Hormones are only one component of the many factors that contribute to normal sexual function in women. Further research is needed as to the impact of hormones and endocrine disorders on female sexual dysfunction and the benefits and risks of hormonal therapies. Wierman ME, Nappi RE, Avis N, Davis SR, Labrie F, Rosner W, and Shifren JL. Endocrine aspects of women's sexual function. J Sex Med 2010;7:561-585.
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- 2010
15. A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes
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May C. M. Pian-Smith, Jan L. Shifren, Peter Valaskatgis, Remy R Coeytaux, Claudine Legault, Nancy E. Avis, and Wunian Chen
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Adult ,medicine.medical_specialty ,Acupuncture Therapy ,Traditional Chinese medicine ,Placebo ,law.invention ,Quality of life ,Randomized controlled trial ,law ,Acupuncture ,Humans ,Medicine ,Dry needling ,business.industry ,Obstetrics and Gynecology ,Middle Aged ,Placebo Effect ,medicine.disease ,Menopause ,Hot Flashes ,Quality of Life ,Physical therapy ,Female ,business ,Body mass index - Abstract
To investigate the feasibility of conducting a randomized trial of the effect of acupuncture in decreasing hot flashes in peri- and postmenopausal women.Fifty-six women ages 44 to 55 with no menses in the past 3 months and at least four hot flashes per day were recruited from two clinical centers and randomized to one of three treatment groups: usual care (n = 19), sham acupuncture (n = 18), or Traditional Chinese Medicine acupuncture (n = 19). Acupuncture treatments were scheduled twice weekly for 8 consecutive weeks. The sham acupuncture group received shallow needling in nontherapeutic sites. The Traditional Chinese Medicine acupuncture group received one of four treatments based on a Traditional Chinese Medicine diagnosis. Usual care participants were instructed to not initiate any new treatments for hot flashes during the study. Daily diaries were used to track frequency and severity of hot flashes. The mean daily index score was based on the number of mild, moderate, and severe hot flashes. Follow-up analyses were adjusted for baseline values, clinical center, age, and body mass index.There was a significant decrease in mean frequency of hot flashes between weeks 1 and 8 across all groups (P = 0.01), although the differences between the three study groups were not significant. However, the two acupuncture groups showed a significantly greater decrease than the usual care group (P0.05), but did not differ from each other. Results followed a similar pattern for the hot flash index score. There were no significant effects for changes in hot flash interference, sleep, mood, health-related quality of life, or psychological well-being.These results suggest either that there is a strong placebo effect or that both traditional and sham acupuncture significantly reduce hot flash frequency.
- Published
- 2008
16. Surgical menopause
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Jan L. Shifren and Nancy E. Avis
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Libido ,medicine.medical_specialty ,Hysterectomy ,business.industry ,Mental Disorders ,Ovariectomy ,medicine.medical_treatment ,General surgery ,Obstetrics and Gynecology ,Oophorectomy ,Human sexuality ,Mental health ,Surgery ,Surgical Menopause ,Mood ,Risk Factors ,medicine ,Humans ,Female ,Menopause ,business ,Sexual function ,Sexuality - Abstract
Objective Women anticipating surgical menopause often have significant concerns regarding the effects of surgery on psychological well-being and sexuality. Results The impact of hysterectomy, often with concurrent oophorectomy, on well-being and sexuality will vary depending on many factors. These include a woman's preoperative mental health and sexual function, the indications for surgery, and the specific procedure being performed. Whether or not estrogen therapy is an option also will affect a woman's postoperative symptoms and experience of surgical menopause. Conclusions The majority of research on the effects of surgical menopause shows improved psychological well-being and sexual function after hysterectomy for benign disease. Women with depression or sexual problems preoperatively are at increased risk for experiencing a worsening of mood and libido postoperatively.
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- 2007
17. Nonhormonal management of menopause-associated vasomotor symptoms: 2015 position statement of The North American Menopause Society
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Marla Shapiro, Maida Taylor, Nanette Santoro, Janet S. Carpenter, Andrew M. Kaunitz, Peter F. Schnatz, Pauline M. Maki, Gloria A. Richard-Davis, JoAnn V. Pinkerton, Katherine M. Newton, Lynnette Leidy Sievert, Wulf H. Utian, Howard N. Hodis, Sheryl A. Kingsberg, Margery Gass, Jan L. Shifren, Caitlin Pike, James H. Liu, and Isaac Schiff
- Subjects
Position statement ,medicine.medical_specialty ,Relaxation ,Alternative medicine ,Behavior Therapy ,medicine ,Humans ,Vascular Diseases ,Exercise ,Health Education ,Societies, Medical ,Gynecology ,Vasomotor ,Cognitive Behavioral Therapy ,business.industry ,Yoga ,Obstetrics and Gynecology ,medicine.disease ,United States ,Post menopause ,Menopause ,Vasomotor System ,Paroxetine ,Family medicine ,Hot Flashes ,Practice Guidelines as Topic ,Women's Health ,Female ,business - Abstract
To update and expand The North American Menopause Society's evidence-based position on nonhormonal management of menopause-associated vasomotor symptoms (VMS), previously a portion of the position statement on the management of VMS.NAMS enlisted clinical and research experts in the field and a reference librarian to identify and review available evidence. Five different electronic search engines were used to cull relevant literature. Using the literature, experts created a document for final approval by the NAMS Board of Trustees.Nonhormonal management of VMS is an important consideration when hormone therapy is not an option, either because of medical contraindications or a woman's personal choice. Nonhormonal therapies include lifestyle changes, mind-body techniques, dietary management and supplements, prescription therapies, and others. The costs, time, and effort involved as well as adverse effects, lack of long-term studies, and potential interactions with medications all need to be carefully weighed against potential effectiveness during decision making.Clinicians need to be well informed about the level of evidence available for the wide array of nonhormonal management options currently available to midlife women to help prevent underuse of effective therapies or use of inappropriate or ineffective therapies. Recommended: Cognitive-behavioral therapy and, to a lesser extent, clinical hypnosis have been shown to be effective in reducing VMS. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management of VMS, although other selective serotonin reuptake/norepinephrine reuptake inhibitors, gabapentinoids, and clonidine show evidence of efficacy. Recommend with caution: Some therapies that may be beneficial for alleviating VMS are weight loss, mindfulness-based stress reduction, the S-equol derivatives of soy isoflavones, and stellate ganglion block, but additional studies of these therapies are warranted. Do not recommend at this time: There are negative, insufficient, or inconclusive data suggesting the following should not be recommended as proven therapies for managing VMS: cooling techniques, avoidance of triggers, exercise, yoga, paced respiration, relaxation, over-the-counter supplements and herbal therapies, acupuncture, calibration of neural oscillations, and chiropractic interventions. Incorporating the available evidence into clinical practice will help ensure that women receive evidence-based recommendations along with appropriate cautions for appropriate and timely management of VMS.
- Published
- 2015
18. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis
- Author
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Janet S, Carpenter, Susan D, Reed, Katherine A, Guthrie, Joseph C, Larson, Katherine M, Newton, R Jane, Lau, Lee A, Learman, and Jan L, Shifren
- Subjects
Adult ,Original Research—Outcomes Assessment ,Sexual Behavior ,Quality of Life ,Female Sexual Distress Scale Revised ,Female ,Menopause - Abstract
Introduction The Female Sexual Distress Scale-Revised (FSDS-R) was created and validated to assess distress associated with impaired sexual function, but it is lengthy for use in clinical practice and research when assessing sexual function is not a primary objective. Aim The study aims to evaluate whether a single item from the FSDS-R could be identified to use to screen midlife women for bothersome diminution in sexual function based on three criteria: (i) highly correlated with total scores; (ii) correlated with commonly assessed domains of female sexual functioning; and (iii) able to differentiate between women reporting high and low sexual concerns during the prior month. Methods Data from 93 midlife women were collected by the Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) research network. Main Outcome Measures Women completed the FSDS-R, Female Sexual Function Index (FSFI), and Menopausal Quality of Life Scale (MENQOL). Those who reported a change in the past month on the MENQOL sexual were categorized into a high sexual concerns group, while all others were categorized into a low sexual concerns group. Results Women were an average of 54.6 years old (SD 3.1) and mostly Caucasian (77.4%), college educated (60.2%), married/living as married (64.5%), and postmenopausal (79.6%). The FSDS-R item number 1 “Distressed about sex life” was: (i) highly correlated with FSDS-R total scores (r = 0.90); (ii) moderately correlated with FSFI total scores (r = −0.38) and FSFI desire (r = −0.37) and satisfaction domains (r = −0.40); and (iii) showed one of the largest mean differences between high and low sexual concerns groups (P
- Published
- 2015
19. Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women
- Author
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Kathryn Wekselman, Patricia Bearnson, Sheila O'Neill, Arthur Waldbaum, Leonard R. Derogatis, Akshay Buch, Michèle Moreau, Norman Kakos, Robin Kroll, Jan L. Shifren, Susan R. Davis, Cynthia Rodenberg, Stephen Levine, Céline Bouchard, and Christine Derzko
- Subjects
Adult ,medicine.medical_specialty ,medicine.drug_class ,Sexual Behavior ,Population ,Physiology ,Administration, Cutaneous ,Placebo ,Sex hormone-binding globulin ,Double-Blind Method ,Humans ,Medicine ,Testosterone ,Sexual Dysfunctions, Psychological ,education ,Aged ,Libido ,Gynecology ,education.field_of_study ,biology ,business.industry ,Obstetrics and Gynecology ,Testosterone (patch) ,Hypoactive sexual desire disorder ,Middle Aged ,medicine.disease ,Sexual desire ,Treatment Outcome ,Estrogen ,Androgens ,biology.protein ,Female ,Menopause ,business - Abstract
OBJECTIVE To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause. DESIGN A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N = 549). Women were randomized to receive testosterone 300 microg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24). RESULTS A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels < or = 160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels < or = 160 nmol/L, mean change of 2.1 +/- 0.28 versus 0.5 +/- 0.23 episodes/4 weeks; P < 0.0001; intent-to-treat population, mean change from baseline of 1.9 +/- 0.26 versus 0.5 +/- 0.21 episodes/4 weeks, P < 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated. CONCLUSIONS Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.
- Published
- 2006
20. Short-Term Use of Estradiol for Depression in Perimenopausal and Postmenopausal Women: A Preliminary Report
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Claudio N. Soares, Allison B. Alexander, Jennifer R. Poitras, Lee S. Cohen, Jan L. Shifren, and Jennifer Prouty
- Subjects
Adult ,medicine.medical_specialty ,Personality Inventory ,medicine.drug_class ,Osteoporosis ,Administration, Cutaneous ,Internal medicine ,medicine ,Humans ,Depression (differential diagnoses) ,Climacteric ,Psychiatric Status Rating Scales ,Gynecology ,Depressive Disorder ,Estradiol ,Vasomotor ,business.industry ,Estrogen Replacement Therapy ,Middle Aged ,medicine.disease ,Postmenopause ,Menopause ,Psychiatry and Mental health ,Treatment Outcome ,Sexual dysfunction ,Estrogen ,Antidepressant ,Female ,medicine.symptom ,business ,Psychosocial - Abstract
The authors examined the effect of a 4-week course of estrogen therapy on depression in perimenopausal and postmenopausal women.Twenty-two depressed women who were either perimenopausal (N=10) or postmenopausal (N=12) received open-label treatment with transdermal 17beta-estradiol (100 micro g/day) for 4 weeks. The Montgomery-Asberg Depression Rating Scale and the Beck Depression Inventory were used to assess depressive symptoms, the Greene Climacteric Scale was used to assess menopause-related symptoms, and the Clinical Global Impression (CGI) was used to assess global clinical improvement in these women at baseline and after treatment. Remission of depression was defined as a score10 on the Montgomery-Asberg Depression Rating Scale and a score/=2 on the CGI at week 4.Remission of depression was noted in eight of the 20 women who completed the study; two of these women were postmenopausal, and six were perimenopausal. Antidepressant response was not associated with severity or subtypes of depression at study entry or with concomitant improvement in menopause-related symptoms.Some perimenopausal women with depression may benefit from short-term use of estrogen therapy, and its role for postmenopausal depressed women warrants further investigation. Antidepressant benefit associated with estrogen therapy may be independent of improvement in physical symptoms.
- Published
- 2003
21. Medical therapy for female sexual dysfunction
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Jan L. Shifren and Alice Mark
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Gynecology ,medicine.medical_specialty ,business.industry ,medicine.drug_class ,Sildenafil ,Female sexual dysfunction ,Obstetrics and Gynecology ,Tibolone ,medicine.disease ,Menopause ,chemistry.chemical_compound ,Sexual dysfunction ,chemistry ,Estrogen ,Epidemiology ,Etiology ,medicine ,medicine.symptom ,Intensive care medicine ,business ,General Nursing ,medicine.drug - Abstract
Sexual dysfunction is an extremely common problem in the gynecologic patient population, affecting over 40% of women. There is little consensus, however, as to the appropriate treatment of women with sexual dysfunction. This review will evaluate the epidemiology and etiology of sexual dysfunction including menopause, aging, hormone deficiency, and vascular insufficiency. It will then evaluate some potential medical therapies for female sexual dysfunction in terms of their risks and benefits. It will specifically address the use of estrogen and androgen supplementation, dehydroepiandrosterone, tibolone, and sildenafil. All of these therapies have shown some benefit in select patient populations. However, large-scale, randomized placebo-controlled double-blind trials remain to be done to establish the true long-term efficacy and side effects of these interventions.
- Published
- 2003
22. The North American Menopause Society at 25 years: celebrating our history and looking to the future
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Wulf H, Utian, Isaac, Schiff, Fredi, Kronenberg, Jan L, Shifren, and Margery L S, Gass
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Gerontology ,business.industry ,Obstetrics and Gynecology ,History, 20th Century ,medicine.disease ,History, 21st Century ,Menopause ,North America ,medicine ,Humans ,Female ,business ,Societies, Medical - Published
- 2014
23. Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes
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Katherine M. Newton, Chancellor Hohensee, Andrea Z. LaCroix, Bette J. Caan, Barbara Sternfeld, JoAnn E. Manson, Julie L. Otte, Nancy Fugate Woods, Ellen W. Freeman, Janet S. Carpenter, Katherine A. Guthrie, Susan D. Reed, Jan L. Shifren, Kristine E. Ensrud, Carol A. Landis, and Hadine Joffe
- Subjects
Aging ,Venlafaxine Hydrochloride ,menopause ,Venlafaxine ,Medical and Health Sciences ,law.invention ,Pittsburgh Sleep Quality Index ,hot flashes ,Randomized controlled trial ,Hot flash ,law ,venlafaxine ,Sleep Initiation and Maintenance Disorders ,Insomnia ,randomized trial ,Estradiol ,Biological Sciences ,Middle Aged ,Effects of Estradiol and Venlafaxine on Insomnia in Women with Hot Flashes ,Menopause ,Anesthesia ,6.1 Pharmaceuticals ,Female ,medicine.symptom ,Sleep Research ,medicine.drug ,medicine.medical_specialty ,Clinical Trials and Supportive Activities ,Placebo ,Double-Blind Method ,Clinical Research ,Physiology (medical) ,medicine ,Humans ,sleep ,Gynecology ,Neurology & Neurosurgery ,business.industry ,Contraception/Reproduction ,Psychology and Cognitive Sciences ,Evaluation of treatments and therapeutic interventions ,Estrogens ,medicine.disease ,Cyclohexanols ,Estrogen ,Perimenopause ,Hot Flashes ,Neurology (clinical) ,business ,Sleep - Abstract
Author(s): Ensrud, Kristine E; Guthrie, Katherine A; Hohensee, Chancellor; Caan, Bette; Carpenter, Janet S; Freeman, Ellen W; LaCroix, Andrea Z; Landis, Carol A; Manson, JoAnn; Newton, Katherine M; Otte, Julie; Reed, Susan D; Shifren, Jan L; Sternfeld, Barbara; Woods, Nancy F; Joffe, Hadine | Abstract: Study objectivesDetermine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes.Design3-arm double-blind randomized trial. Participants assigned in a 2:2:3 ratio to 17β estradiol 0.5 mg/day (n = 97), venlafaxine XR 75 mg/day (n = 96), or placebo (n = 146) for 8 weeks.SettingAcademic research centers.Participants339 community-dwelling perimenopausal and postmenopausal women with ≥2 bothersome hot flashes per day.Measurements and resultsInsomnia symptoms (Insomnia Severity Index [ISI]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at baseline, week 4 and 8; 325 women (96%) provided ISI data and 312 women (92%) provided PSQI data at baseline and follow-up. At baseline, mean (SD) hot flash frequency was 8.1/day (5.3), mean ISI was 11.1 (6.0), and mean PSQI was 7.5 (3.4). Mean (95% CI) change from baseline in ISI at week 8 was -4.1 points (-5.3 to -3.0) with estradiol, -5.0 points (-6.1 to -3.9) with venlafaxine, and -3.0 points (-3.8 to -2.3) with placebo (P overall treatment effect vs. placebo 0.09 for estradiol and 0.007 for venlafaxine). Mean (95% CI) change from baseline in PSQI at week 8 was -2.2 points (-2.8 to -1.6) with estradiol, -2.3 points (-2.9 to -1.6) with venlafaxine, and -1.2 points (-1.7 to -0.8) with placebo (P overall treatment effect vs. placebo 0.04 for estradiol and 0.06 for venlafaxine).ConclusionsAmong perimenopausal and postmenopausal women with hot flashes, both low dose oral estradiol and low-dose venlafaxine compared with placebo modestly reduced insomnia symptoms and improved subjective sleep quality.Clinical trial registrationNCT01418209 at www.clinicaltrials.gov.
- Published
- 2014
24. Transdermal Testosterone Treatment in Women with Impaired Sexual Function after Oophorectomy
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Jan L. Shifren, Glenn D. Braunstein, James A. Simon, Peter R. Casson, John E. Buster, Geoffrey P. Redmond, Regula E. Burki, Elizabeth S. Ginsburg, Raymond C. Rosen, Sandra R. Leiblum, Kim E. Caramelli, Kirtley P. Jones, Claire A. Daugherty, and Norman A. Mazer
- Subjects
Adult ,medicine.medical_specialty ,Ovariectomy ,Sexual Behavior ,medicine.medical_treatment ,Administration, Cutaneous ,Hysterectomy ,Placebo ,law.invention ,Double-Blind Method ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Testosterone ,Gonadal Steroid Hormones ,Cross-Over Studies ,Depression ,business.industry ,Oophorectomy ,Estrogens ,Hypoactive sexual desire disorder ,Testosterone (patch) ,General Medicine ,Middle Aged ,medicine.disease ,Crossover study ,Postmenopause ,Menopause ,Mental Health ,Endocrinology ,Drug Therapy, Combination ,Female ,business - Abstract
The ovaries provide approximately half the circulating testosterone in premenopausal women. After bilateral oophorectomy, many women report impaired sexual functioning despite estrogen replacement. We evaluated the effects of transdermal testosterone in women who had impaired sexual function after surgically induced menopause.Seventy-five women, 31 to 56 years old, who had undergone oophorectomy and hysterectomy received conjugated equine estrogens (at least 0.625 mg per day orally) and, in random order, placebo, 150 microg of testosterone, and 300 microg of testosterone per day transdermally for 12 weeks each. Outcome measures included scores on the Brief Index of Sexual Functioning for Women, the Psychological General Well-Being Index, and a sexual-function diary completed over the telephone.The mean (+/-SD) serum free testosterone concentration increased from 1.2+/-0.8 pg per milliliter (4.2+/-2.8 pmol per liter) during placebo treatment to 3.9+/-2.4 pg per milliliter (13.5+/-8.3 pmol per liter) and 5.9+/-4.8 pg per milliliter (20.5+/-16.6 pmol per liter) during treatment with 150 and 300 microg of testosterone per day, respectively (normal range, 1.3 to 6.8 pg per milliliter [4.5 to 23.6 pmol per liter]). Despite an appreciable placebo response, the higher testosterone dose resulted in further increases in scores for frequency of sexual activity and pleasure-orgasm in the Brief index of Sexual Functioning for Women (P=0.03 for both comparisons with placebo). At the higher dose the percentages of women who had sexual fantasies, masturbated, or engaged in sexual intercourse at least once a week increased two to three times from base line. The positive-well-being, depressed-mood, and composite scores of the Psychological General Well-Being Index also improved at the higher dose (P=0.04, P=0.03, and P=0.04, respectively, for the comparison with placebo), but the scores on the telephone-based diary did not increase significantly.In women who have undergone oophorectomy and hysterectomy, transdermal testosterone improves sexual function and psychological well-being.
- Published
- 2000
25. NAMS supports judicious use of systemic hormone therapy for women aged 65 years and older
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Margery Gass, Andrew M. Kaunitz, Pauline M. Maki, Peter F. Schnatz, Lynnette Leidy Sievert, Marla Shapiro, and Jan L. Shifren
- Subjects
Pediatrics ,medicine.medical_specialty ,business.industry ,Contraindications ,medicine.medical_treatment ,Estrogen Replacement Therapy ,Obstetrics and Gynecology ,Symptom assessment ,medicine.disease ,Menopause ,Sexual Dysfunction, Physiological ,Text mining ,Hot Flashes ,medicine ,Humans ,Female ,Hormone therapy ,Symptom Assessment ,Estrogen replacement therapy ,business - Published
- 2015
26. A randomized, open-label, crossover study comparing the effects of oral versus transdermal estrogen therapy on serum androgens, thyroid hormones, and adrenal hormones in naturally menopausal women
- Author
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Marilyn Mcilwain, Sophie Desindes, Norman A. Mazer, Gheorghe Doros, and Jan L. Shifren
- Subjects
Adult ,medicine.medical_specialty ,Globulin ,medicine.medical_treatment ,Administration, Oral ,Administration, Cutaneous ,Transdermal estrogen ,Internal medicine ,medicine ,Humans ,Testosterone ,Progesterone ,Transdermal ,Aged ,Cross-Over Studies ,Estrogens, Conjugated (USP) ,biology ,business.industry ,Estrogen Replacement Therapy ,Obstetrics and Gynecology ,Middle Aged ,Crossover study ,Thyroxine ,Endocrinology ,Treatment Outcome ,biology.protein ,Female ,Serum androgens ,Hormone therapy ,Menopause ,business ,Carrier Proteins ,Hormone - Abstract
Objective: To compare the changes induced by oral versus transdermal estrogen therapy on the total and free serum concentrations of testosterone (T), thyroxine (T 4 ), and cortisol (C) and the concentrations of their serum binding globulins sex hormone-binding globulin, thyroxine-binding globulin, and cortisol-binding globulin in naturally menopausal women. Design: Randomized, open-label, crossover. Interventions included a 6-week withdrawal from previous hormone therapy (baseline), followed in randomized order by 12 weeks of oral conjugated equine estrogens (CEE) (0.625 mg/d) and 12 weeks of transdermal estradiol (TD E 2 ) (0.05 mg/d), with oral micronized progesterone (100 mg/d) given continuously during both transdermal estrogen therapy regimens. Results: Twenty-seven women were enrolled in the study, and 25 completed both treatment periods. The mean (SD) percentage changes from baseline of sex hormone-binding globulin, total T, and free T with oral CEE were +132.1% (74.5%), +16.4% (43.8%), and -32.7% (25.9%), respectively, versus +12.0% (25.1%), +1.2% (43.7%), and +1.0% (45.0%) with TD E 2 . The mean (SD) percentage changes of thyroxine-binding globulin, total T 4 , and free T 4 with oral CEE were +39.9% (20.1%), +28.4% (29.2%), and -10.4% (22.3%), respectively, versus +0.4% (11.1%), -0.7% (16.5%), and +0.2% (26.6%) with TD E 2 . The mean (SD) percentage changes of cortisol-binding globulin, total C, and free C with oral CEE were +18.0% (19.5%), +29.2% (46.3%), and +50.4% (126.5%), respectively, versus -2.2% (11.3%), -6.7% (30.8%), and +1.8% (77.1%) with TD E 2 . Concentrations of all hormones and binding globulins were significantly different (P < 0.003) during administration of oral versus transdermal estrogen therapy, except for free T 4 and free C. Conclusions: Compared with oral CEE, TD E 2 exerts minimal effects on the total and free concentrations of T, T 4 and C and their binding proteins.
- Published
- 2007
27. Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial
- Author
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Jan L. Shifren, Nelson B. Watts, Akshay Buch, Gloria Bachman, Molly Katz, James A. Simon, Dale A. Sundwall, J. Lucas, John E. Buster, Oscar A. Aguirre, Cynthia Rodenberg, and Glenn D. Braunstein
- Subjects
Adult ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,Ovariectomy ,Sexual Behavior ,Placebo-controlled study ,Menopause, Premature ,Placebo ,Administration, Cutaneous ,Hysterectomy ,law.invention ,Randomized controlled trial ,Double-Blind Method ,law ,Multicenter trial ,Internal medicine ,Internal Medicine ,medicine ,Humans ,Testosterone ,Sexual Dysfunctions, Psychological ,Gonadal Steroid Hormones ,Aged ,Libido ,Gynecology ,Dose-Response Relationship, Drug ,business.industry ,Oophorectomy ,Hypoactive sexual desire disorder ,Testosterone (patch) ,Estrogens ,Middle Aged ,medicine.disease ,Menopause ,Sexual desire ,Treatment Outcome ,Androgens ,Female ,business - Abstract
Background Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women. Methods A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 μg/d (n = 107), 300 μg/d (n = 110), or 450 μg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures. Results Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-μg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P = .05) and in frequency of satisfying sexual activity (79% vs 43%; P = .049). The 150-μg/d group showed no evidence of a treatment effect. The 450-μg/d group also was not statistically different from the 300-μg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks ( P = .06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed. Conclusions The 300-μg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.
- Published
- 2005
28. The role of androgens in female sexual dysfunction
- Author
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Jan L, Shifren
- Subjects
Drug Implants ,Clinical Trials as Topic ,Hormone Replacement Therapy ,Chemistry, Pharmaceutical ,Libido ,Patient Selection ,Administration, Oral ,Dehydroepiandrosterone ,Administration, Cutaneous ,Injections, Intramuscular ,Severity of Illness Index ,Sex Counseling ,Treatment Outcome ,Premenopause ,Methyltestosterone ,Androgens ,Humans ,Female ,Testosterone ,Sexual Dysfunctions, Psychological ,Menopause ,Arousal ,Gels - Abstract
There are many treatment options for female sexual dysfunction (FSD), with the optimal therapy depending on the etiology of the problem. The cause of sexual dysfunction is multifactorial and may include psychological problems such as depression or anxiety disorders, conflict within the relationship, partner performance and technique, issues relating to prior abuse, medical illness, medications, fatigue, stress, or gynecological problems that make sexual activity uncomfortable. The role of low androgen concentrations in FSD is gaining increasing attention. Available therapeutic options include adjusting medications, counseling, treating depression or anxiety, reducing stress and fatigue, sex therapy, devices, estrogen therapy for genitourinary atrophy, and possibly vasoactive substances. Although no androgen therapies are currently approved by the Food and Drug Administration for FSD, they are being used in clinical practice, and early clinical trial results suggest that they may be both effective and safe in the treatment of FSD, specifically low libido. Androgen therapy should be considered primarily in women who have a physiological reason for reduced androgen concentrations, including aging, hypopituitarism, oophorectomy, or adrenal insufficiency. Products in use include oral methyltestosterone and dehydroepiandrosterone, topical testosterone ointment, and testosterone implants and injections. Products available for men, including skin patches and gels, are currently being studied at doses appropriate for women. Possible risks include hirsutism, acne, liver dysfunction, lowering of the voice, adverse lipid changes, virilization of a female fetus, and, as androgens are aromatized to estrogens, potentially the risks of estrogen therapy.
- Published
- 2004
29. Transdermal testosterone for women: a new physiological approach for androgen therapy
- Author
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Jan L. Shifren and Norman A. Mazer
- Subjects
medicine.medical_specialty ,HIV Wasting Syndrome ,Administration, Cutaneous ,Transdermal estrogen ,Pharmacokinetics ,Internal medicine ,Medicine ,Humans ,Drug Interactions ,Testosterone ,Transdermal ,Clinical Trials as Topic ,business.industry ,Obstetrics and Gynecology ,Testosterone (patch) ,Estrogens ,General Medicine ,medicine.disease ,Testosterone Gel ,Menopause ,Sexual Dysfunction, Physiological ,Sexual dysfunction ,Endocrinology ,Androgen Therapy ,Female ,medicine.symptom ,business - Abstract
Transdermal testosterone patches and topically applied gels have become well accepted for the treatment of testosterone deficiency in men and are currently being developed in appropriate dosage strengths for androgen therapy in women. The furthest developed among these products is an investigational testosterone matrix patch which is now in phase III clinical trials for the treatment of sexual dysfunction in oophorectomized and naturally menopausal women. This review article discusses the biopharmaceutical rationale for the transdermal delivery of testosterone to women, illustrates and quantitatively analyzes the pharmacokinetics and metabolism of the testosterone matrix patch and a recently investigated testosterone gel, and summarizes the efficacy and safety data that have been reported in phase II studies of the testosterone matrix patch in surgically menopausal women with sexual dysfunction and HIV-infected women with the AIDS wasting syndrome. The different effects of oral and transdermal estrogen therapy (ET) on the concentrations of total and free testosterone attained with the testosterone matrix patch are contrasted. Although still in development, transdermal testosterone therapy appears to be a promising new approach for providing physiologically based androgen therapy to women.
- Published
- 2003
30. Efficacy of citalopram as a monotherapy or as an adjunctive treatment to estrogen therapy for perimenopausal and postmenopausal women with depression and vasomotor symptoms
- Author
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Claudio N. Soares, Allison B. Alexander, Jennifer Prouty, Jennifer R. Poitras, Lee S. Cohen, and Jan L. Shifren
- Subjects
Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Citalopram ,Internal medicine ,medicine ,Humans ,Depression (differential diagnoses) ,Climacteric ,Psychiatric Status Rating Scales ,Depressive Disorder ,Vasomotor ,Estradiol ,business.industry ,Estrogen Replacement Therapy ,Hormone replacement therapy (menopause) ,Middle Aged ,medicine.disease ,Antidepressive Agents ,Menopause ,Postmenopause ,Vasomotor System ,Psychiatry and Mental health ,Endocrinology ,Treatment Outcome ,Adjunctive treatment ,Anxiety ,Drug Therapy, Combination ,Female ,Hormone therapy ,medicine.symptom ,business ,medicine.drug - Abstract
BACKGROUND Women frequently report depressive and vasomotor symptoms during the menopausal transition. Hormone therapy has been shown to improve some of these symptoms, although its safety as a long-term treatment has been questioned. It is still unclear whether the use of antidepressants alone may alleviate menopause-related mood and vasomotor symptoms or enhance the response observed with short-term use of estrogen therapy. METHOD Perimenopausal and postmenopausal women with depressive disorders (DSM-IV criteria) and menopause-related symptoms received treatment with 20 to 60 mg/day of citalopram alone (N = 22) or adjunctive to estrogen therapy (N = 13). Adjunctive treatment was offered to subjects who had failed to show remission of depression after 4 weeks with estrogen therapy (estradiol [E(2)]) alone. Depressive symptoms, menopause-related symptoms, and global clinical improvement were assessed at baseline and at endpoint of adjunctive treatment (8 weeks) or citalopram monotherapy (12 weeks). Remission of depression was defined as a score of < 10 on the Montgomery-Asberg Depression Rating Scale and a score of < or = 2 on the Clinical Global Impressions scale at endpoint. Data were collected from November 2000 to February 2002. RESULTS Twelve women (92.3%) concluded the 8-week adjunctive treatment; 11 subjects (91.6%) achieved full remission of depression. Symptoms that had persisted after an initial 4-week treatment with E(2) alone (e.g., tension, anxiousness, tiredness, and difficulty in concentrating) improved significantly (p
- Published
- 2003
31. Androgen deficiency in the oophorectomized woman
- Author
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Jan L. Shifren
- Subjects
Libido ,Gynecology ,medicine.medical_specialty ,Hysterectomy ,business.industry ,Hormone Replacement Therapy ,medicine.medical_treatment ,Ovariectomy ,Obstetrics and Gynecology ,Oophorectomy ,Testosterone (patch) ,Middle Aged ,medicine.disease ,Menopause ,Hormone replacement therapy (female-to-male) ,Reproductive Medicine ,Androgen deficiency ,Androgens ,Medicine ,Humans ,Female ,business ,Sexual function ,Sexuality - Abstract
Women experience a significant decline in circulating androgen concentrations after bilateral oophorectomy. Despite several limitations, studying women after oophorectomy remains a good model for investigating the effects of both androgen deficiency and androgen replacement. Current data show that most women experience satisfying sexual lives after hysterectomy and bilateral oophorectomy. This is reassuring since elective oophorectomy at the time of hysterectomy is an appropriate option for many women. Oophorectomized women, however, are more likely to report a worsening of sexual function after hysterectomy compared with women who retain their ovaries. Specifically, adverse changes in libido and orgasmic response are more likely in oophorectomized women. After bilateral oophorectomy, women also appear more likely to experience decreased positive psychological well-being. Studies of both the consequences of oophorectomy and the effects of testosterone replacement are consistent with an important role for androgens in female sexual function and psychological well-being.
- Published
- 2002
32. Neuropsychological effects of methyltestosterone in women using menopausal hormone replacement
- Author
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Isaac Schiff, Joan Friebely, Quentin R. Regestein, and Jan L. Shifren
- Subjects
Adult ,medicine.medical_specialty ,medicine.drug_class ,Hormone Replacement Therapy ,Hormone replacement ,Administration, Oral ,Motor Activity ,Drug Administration Schedule ,chemistry.chemical_compound ,Double-Blind Method ,Internal medicine ,Methyltestosterone ,Surveys and Questionnaires ,medicine ,Humans ,Psychological testing ,Aged ,Gynecology ,Cross-Over Studies ,business.industry ,Depression ,Neuropsychology ,Estrogens ,General Medicine ,Middle Aged ,Androgen ,Esterified estrogen ,chemistry ,Estrogen ,Female ,Menopause ,business ,medicine.drug - Abstract
To observe the effects of androgen replacement on neuropsychological measures in menopausal women, healthy menopausal women already using replacement estrogen were studied in a randomized, double-blind, active placebo-controlled, crossover comparison between two 8-week periods of treatment with (1) 0.625 mg oral esterified estrogen (E) alone and (2) in combination with 1.25 mg oral methyltestosterone (meT). After an initial baseline session, data were gathered at the end of two treatment periods. Scores on standardized psychological tests and computerized reaction times were compared between treatments, as was an overall outcome score that combined all measures. Added meT significantly improved scores on a test of complex information processing, the Switching Attention Test, but not on other tests. Mean outcome score showed no net change and wide variation. Fourteen subjects had outcome scores1 SD from the mean, and 21 had no change. In the estrogen alone condition, three measures predicted favorable outcome with added meT: surgically compromised ovarian function, fewer physical symptoms, and higher score on a self-image measure of creativity. Added meT treatment may improve complex information processing. Despite wide disparities in outcome, an increased chance of overall improvement may be predicted by specific pretreatment measures.
- Published
- 2001
33. The aging ovary
- Author
-
Jan L. Shifren and Isaac Schiff
- Subjects
endocrine system ,medicine.medical_specialty ,Aging ,endocrine system diseases ,medicine.drug_class ,Ovary ,Sex hormone-binding globulin ,Internal medicine ,Sex Hormone-Binding Globulin ,medicine ,Humans ,Testosterone ,biology ,Adrenal gland ,business.industry ,Estrogens ,General Medicine ,Androgen ,medicine.disease ,female genital diseases and pregnancy complications ,Menopause ,medicine.anatomical_structure ,Endocrinology ,Estrogen ,biology.protein ,Androgens ,Female ,Gonadotropin ,business ,hormones, hormone substitutes, and hormone antagonists - Abstract
During reproductive life, ovarian steroid biosynthesis is gonadotropin dependent and occurs in theca and granulosa cells. In the menopausal ovary, there is atresia of ovarian follicles, with sparing of the androgen-producing theca-interstitial cell component. The aging ovary, therefore, produces significantly reduced amounts of estrogen, with continued, though decreased, androgen production. After menopause, ovarian estradiol biosynthesis is minimal, with circulating estrogen being derived principally from peripheral aromatization of ovarian and adrenal androgens. Androgen biosynthesis from the adrenal gland, in addition to that from the ovary, decreases with age. Although ovarian androgen production declines with age, there is not an abrupt decrease as is seen with ovarian estrogen levels at the time of menopause. The biological activity of these steroids, either before or after menopause, depends on the amount of steroid available in the unbound fraction. To this end, sex hormone-binding globulin (SHBG) levels are an important determinant of hormone action. Not only does the concentration of SHBG influence the biological effect of testosterone and estradiol, but these steroids also regulate SHBG concentrations.
- Published
- 2000
34. Menopause, Me and You???The Sound of Women Pausing
- Author
-
Jan L. Shifren and Ravit Nahum
- Subjects
Menopause ,medicine.medical_specialty ,geography ,geography.geographical_feature_category ,business.industry ,Obstetrics and Gynecology ,Medicine ,Audiology ,business ,medicine.disease ,Sound (geography) - Published
- 1998
35. Incidence of Sexual Dysfunction in Surgically Menopausal Women
- Author
-
Jan L. Shifren, Norman A. Mazer, and Ravit Nahum
- Subjects
Adult ,medicine.medical_specialty ,Obstetrics ,business.industry ,Ovariectomy ,Incidence (epidemiology) ,Obstetrics and Gynecology ,Middle Aged ,Sexual Dysfunction, Physiological ,Sexual dysfunction ,medicine ,Humans ,Female ,Testosterone ,Menopause ,medicine.symptom ,business - Published
- 1998
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