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Your search keyword '"Bouchard, Céline"' showing total 140 results
Start Over Author "Bouchard, Céline" Publication Type Academic Journals
140 results on '"Bouchard, Céline"'

1. Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: data from the phase 3 clinical trial in Europe and Russia

Author

Bitzer, Johannes, Bouchard, Céline, Zatik, János, Weyers, Steven, Piltonen, Terhi, Suturina, Larisa, Apolikhina, Inna, Gemzell-Danielsson, Kristina, Jost, Maud, Creinin, Mitchell D, and Foidart, Jean-Michel

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Behavioral and Social Science, Clinical Trials and Supportive Activities, Chronic Pain, Pain Research, Humans, Female, Adult, Russia, Young Adult, Premenstrual Syndrome, Europe, Androstenes, Self Report, Middle Aged, Adolescent, Drug Combinations, Surveys and Questionnaires, Dysmenorrhea, Estetrol, E4, E4/drsp, combined oral hormone contraception, menstrual distress questionnaire, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

PurposeTo describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms.Materials and methodsWe used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 - 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ-t-scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain.ResultsOf 1,553 treated participants, 1,398(90.0%), including 531(38%) starters, completed both MDQs. Starters reported improvements for premenstrual Pain (-1.4), Water Retention (-3.3) and Negative Affect (-2.5); and for menstrual Pain (-3.5), Water Retention (-3.4), and Negative Affect (-2.7) (all p 40% of participants for Cramps, Backache and Fatigue (domain Pain), Painful or Tender Breast and Swelling (domain Water Retention) and Mood Swings and Irritability (domain Negative Affect).ConclusionE4/DRSP starters experienced significant improvements in the domains Pain, Water Retention and Negative Affect particularly benefiting those with more severe baseline symptoms. Switchers showed minimal changes.

Published
2024

2. Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials

Author

Jensen, Jeffrey T, Kaunitz, Andrew M, Achilles, Sharon L, Zatik, János, Weyers, Steven, Piltonen, Terhi, Suturina, Larisa, Apolikhina, Inna, Bouchard, Céline, Chen, Melissa J, Apter, Dan, Jost, Maud, Foidart, Jean-Michel, and Creinin, Mitchell D

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, Pediatric, Clinical Research, Prevention, Contraception/Reproduction, Good Health and Well Being, Humans, Pregnancy, Female, United States, Adolescent, Young Adult, Adult, Estetrol, Androstenes, Contraceptives, Oral, Combined, Contraception, Estrogens, Combined oral contraception, Contraceptive efficacy, Drospirenone, E4, Native estrogen, Pearl Index, Clinical Sciences, Paediatrics and Reproductive Medicine, Public Health and Health Services, Obstetrics & Reproductive Medicine, Clinical sciences, Reproductive medicine, Health services and systems
Abstract

ObjectiveTo evaluate overall and subgroup efficacy of an estetrol (E4) 15 mg drospirenone (DRSP) 3 mg oral contraceptive in a 24/4-day regimen.Study designWe pooled efficacy outcomes from 2 pivotal phase 3 contraceptive trials with E4/DRSP conducted in the United States/Canada and Europe/Russia. We assessed Pearl Index (PI; pregnancies per 100 participant-years) and 13-cycle life-table pregnancy rates in at-risk cycles (confirmed intercourse and no other contraceptive use) among participants 16 to 35 years. We calculated PI by age and further subcategorization (contraceptive history and body mass index [BMI]). We performed multivariable analysis using Cox regression to assess impact of potential confounding factors.ResultsAnalyses included 3027 participants, of whom 451 (14.9%) had a BMI ≥30 kg/m2. The pooled PI was 1.52 (95% confidence interval 1.04-2.16) and the 13-cycle life-table pregnancy rate was 1.28% (0.83%-1.73%). We calculated unadjusted pooled PI in participants 16 to 25 years and 26 to 35 years of 1.61 (0.94-2.57) and 1.43 (0.78-2.40), respectively; in new starters and switchers of 1.88 (1.09-3.00) and 1.24 (0.68-2.08), respectively; and by BMI

Published
2022

3. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results

Author

Creinin, Mitchell D, Westhoff, Carolyn L, Bouchard, Céline, Chen, Melissa J, Jensen, Jeffrey T, Kaunitz, Andrew M, Achilles, Sharon L, Foidart, Jean-Michel, and Archer, David F

Subjects
Hematology, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Prevention, Contraception/Reproduction, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Androstenes, Contraceptives, Oral, Combined, Estetrol, Estrogens, Ethinyl Estradiol, Female, Humans, North America, Pregnancy, Drospirenone, Oral contraceptive, Pearl index, Clinical Sciences, Paediatrics and Reproductive Medicine, Public Health and Health Services, Obstetrics & Reproductive Medicine
Abstract

ObjectiveTo assess efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.Study designWomen aged 16 to 50 years with a body mass index ≤35 kg/m2 enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was scheduled at Cycles 2, 4, 7, and 10 and within 3 weeks of completing Cycle 13. Participants used daily diaries to record pill use and vaginal bleeding. We evaluated efficacy outcomes in women 16 to 35 years and bleeding patterns and safety (adverse events [AEs]) in all participants. We assessed overall and method-failure pregnancy rates using the Pearl index (PI) and life-table analysis. Scheduled bleeding included spotting or bleeding starting during the 4-day placebo period or first 3 days of the next cycle.ResultsWe enrolled 1864 women of whom 1674 were 16 to 35 years. Women 16 to 35 years had a PI of 2.65 (95% CI 1.73-3.88), method-failure PI of 1.43 (95% CI 0.7-2.39) and 13-cycle life-table pregnancy rate of 2.1%. Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle; median duration was 4.5 days. Unscheduled bleeding decreased from 30.3% in Cycle 1 to 21.3% to 22.1% during Cycles 2 to 4 and remained stable (15.5% to 19.2%) thereafter. The most frequently reported AEs were headache (5.0%) and metrorrhagia (4.6%). One-hundred thirty-two (7.1%) women discontinued the study early for an AE, most commonly for metrorrhagia (0.9%) and menorrhagia (0.8%). No thromboembolic events occurred.ConclusionE4/DRSP is an effective oral contraceptive with a predictable bleeding pattern for most women and low AE rates.Implications statementA new oral contraceptive with a novel estrogen, estetrol, combined with drospirenone has efficacy and safety within the range of other available oral contraceptives. Large phase 4 studies will be needed to confirm if this combination is associated with an improved adverse event profile or lower thrombosis risk.

Published
2021

7. International Anal Neoplasia Society Guidelines for the Practice of Digital Anal Rectal Examination.

Author

Hillman, Richard John, Berry-Lawhorn, J Michael, Ong, Jason J, Cuming, Tamzin, Nathan, Mayura, Goldstone, Stephen, Richel, Olivier, Barrosso, Luis F, Darragh, Teresa M, Law, Carmella, Bouchard, Céline, Stier, Elizabeth A, Palefsky, Joel M, Jay, Naomi, and International Anal Neoplasia Society

Subjects
International Anal Neoplasia Society, Humans, Anus Neoplasms, Diagnostic Tests, Routine, Early Diagnosis, Image Processing, Computer-Assisted, Quality Assurance, Health Care, Practice Guidelines as Topic, Optical Imaging, Obstetrics & Reproductive Medicine, Clinical Sciences
Abstract

OBJECTIVE:The aim of the study was to develop recommended techniques and quality assurance metrics for the practice of Digital Anal Rectal Examination (DARE). MATERIALS AND METHODS:The International Anal Neoplasia Society undertook a literature review and, using the AGREE II technique, developed guidelines for performing DARE. RESULTS:A consensus was formed regarding the optimum conditions and characteristics of DARE. Several Quality Assurance metrics were developed. CONCLUSIONS:Digital Anal Rectal Examination is a cheap and potentially universally available technique, which has the potential to facilitate the early diagnosis of anal cancers, when they are most amenable to treatment. These guidelines provide a basis for teaching the technique and may be used as for evaluation research.

Published
2019

10. 2016 IANS International Guidelines for Practice Standards in the Detection of Anal Cancer Precursors

Author

Hillman, Richard John, Cuming, Tamzin, Darragh, Teresa, Nathan, Mayura, Berry-Lawthorn, Michael, Goldstone, Stephen, Law, Carmella, Palefsky, Joel, Barroso, Luis F, Stier, Elizabeth A, Bouchard, Céline, Almada, Justine, and Jay, Naomi

Subjects
Cancer, Clinical Research, Prevention, Management of diseases and conditions, 7.3 Management and decision making, Anus Neoplasms, Humans, Precancerous Conditions, anal cancer, precursors, high-grade squamous intraepithelial lesions, anal intraepithelial neoplasia, high-resolution anoscopy, anal cytology, quality assurance, practice standards, diagnostics, Clinical Sciences, Obstetrics & Reproductive Medicine
Abstract

ObjectivesTo define minimum standards for provision of services and clinical practice in the investigation of anal cancer precursors.MethodsAfter initial face to face meetings of experts at the International Papillomavirus meeting in Lisbon, September 17 to 21, 2015, a first version was drafted and sent to key stakeholders. A complete draft was reviewed by the Board of the International Anal Neoplasia Society (IANS) and uploaded to the IANS Web site for all members to provide comments. The final draft was ratified by the IANS Board on June 22, 2016.ResultsThe essential components of a satisfactory high-resolution anoscopy (HRA) were defined. Minimum standards of service provision, basic competencies for clinicians, and standardized descriptors were established. Quality assurance metrics proposed for practitioners included a minimum of 50 HRAs per year and identifying 20 cases or more of anal high-grade squamous intraepithelial lesions (HSILs). Technically unsatisfactory anal cytological samples at first attempt in high-risk populations should occur in less than 5% of cases. Where cytological HSIL has been found, histological HSIL should be identified in ≥ 90% of cases. Duration of HRA should be less than 15 minutes in greater than 90% of cases. Problematic pain or bleeding should be systematically collected and reported by 10% or lesser of patients.ConclusionsThese guidelines propose initial minimum competencies for the clinical practice of HRA, against which professionals can judge themselves and providers can evaluate the effectiveness of training. Once standards have been agreed upon and validated, it may be possible to develop certification methods for individual practitioners and accreditation of sites.

Published
2016

18. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Author

Wheeler, Cosette M, Skinner, S Rachel, Del Rosario-Raymundo, M Rowena, Garland, Suzanne M, Chatterjee, Archana, Lazcano-Ponce, Eduardo, Salmerón, Jorge, McNeil, Shelly, Stapleton, Jack T, Bouchard, Céline, Martens, Mark G, Money, Deborah M, Quek, Swee Chong, Romanowski, Barbara, Vallejos, Carlos S, ter Harmsel, Bram, Prilepskaya, Vera, Fong, Kah Leng, Kitchener, Henry, Minkina, Galina, Lim, Yong Kuei Timothy, Stoney, Tanya, Chakhtoura, Nahida, Cruickshank, Margaret E, Savicheva, Alevtina, da Silva, Daniel Pereira, Ferguson, Murdo, Molijn, Anco C, Quint, Wim G V, Hardt, Karin, Descamps, Dominique, Suryakiran, Pemmaraju V, Karkada, Naveen, Geeraerts, Brecht, Dubin, Gary, and Struyf, Frank

Published
2016
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21. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Author

Skinner, S Rachel, Szarewski, Anne, Romanowski, Barbara, Garland, Suzanne M, Lazcano-Ponce, Eduardo, Salmerón, Jorge, Del Rosario-Raymundo, M Rowena, Verheijen, René H M, Quek, Swee Chong, da Silva, Daniel P, Kitchener, Henry, Fong, Kah Leng, Bouchard, Céline, Money, Deborah M, Ilancheran, Arunachalam, Cruickshank, Margaret E, Levin, Myron J, Chatterjee, Archana, Stapleton, Jack T, Martens, Mark, Quint, Wim, David, Marie-Pierre, Meric, Dorothée, Hardt, Karin, Descamps, Dominique, Geeraerts, Brecht, Struyf, Frank, and Dubin, Gary

Published
2014
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24. Female Genital Cosmetic Surgery

Author

Leyland, Nicholas, Wolfman, Wendy, Allaire, Catherine, Awadalla, Alaa, Best, Carolyn, Dunn, Sheila, Heywood, Mark, Lemyre, Madeleine, Marcoux, Violaine, Menard, Chantal, Potestio, Frank, Rittenberg, David, Singh, Sukhbir, Shapiro, Jodi, Akhtar, Saima, Camire, Bruno, Christilaw, Jan, Corey, Julie, Nelson, Erin, Pierce, Marianne, Robertson, Deborah, Simmonds, Anne, Shaw, Dorothy, Lefebvre, Guylaine, Bouchard, Celine, Blake, Jennifer, Allen, Lisa, and Cassell, Krista

Published
2013
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29. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy

Author

Labrie, Fernand, Derogatis, Leonard, Archer, David F., Koltun, William, Vachon, Andrée, Young, Douglas, Frenette, Louise, Portman, David, Montesino, Marlene, Côté, Isabelle, Parent, Julie, Lavoie, Lyne, Beauregard, Adam, Martel, Céline, Vaillancourt, Mario, Balser, John, Moyneur, Érick, Ackerman, Ronald T., Andruczyk, Eugene, Aqua, Keith, Archer, David F., Belle-Isle, Jasmin, Blank, Steven, Blouin, François, Bouchard, Céline, Chavoustie, Steven E., Cooper, Theodore, Cusan, Leonello, Donovan, Arthur J., Drosman, Steven, Eder, Scott E., Elfassi, Émile, Euband, Charles Dale, Fikry, Sameh, Frenette, Louise, Gervais, Benoît, Goldberg, Cynthia, Grainger, David A., Janzen, Jeannette, Koltun, William, Komer, Lawrence D., Kroll, Robin, Lederman, Samuel N., London, Andrew, McClinton, Joe D., O'Mahony, Michael FJ, O'Mahony, Williaml F., Poindexter, Alfred, III, Portman, David J., Sussman, Steven, Thériault, Guy, Upp, Linda, Vachon, Andrée, Waldbaum, Arthur, and Young, Douglas

Published
2015
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40. Chirurgie esthétique génitale chez la femme

Author

Leyland, Nicholas, Wolfman, Wendy, Allaire, Catherine, Awadalla, Alaa, Best, Carolyn, Dunn, Sheila, Heywood, Mark, Lemyre, Madeleine, Marcoux, Violaine, Menard, Chantal, Potestio, Frank, Rittenberg, David, Singh, Sukhbir, Shapiro, Jodi, Akhtar, Saima, Camire, Bruno, Christilaw, Jan, Corey, Julie, Nelson, Erin, Pierce, Marianne, Robertson, Deborah, Simmonds, Anne, Shaw, Dorothy, Lefebvre, Guylaine, Bouchard, Céline, Blake, Jennifer, Allen, Lisa, and Cassell, Krista

Published
2013
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49. Modeling the Balance of Benefits and Harms of Cervical Cancer Screening with Cytology and Human Papillomavirus Testing.

Author

Malagón, Talía, Mayrand, Marie-Hélène, Ogilvie, Gina, Gotlieb, Walter H., Blake, Jennifer, Bouchard, Céline, Franco, Eduardo L., and Kulasingam, Shalini

Abstract

Background: Benefits of screening should outweigh its potential harms. We compared various metrics to assess the balance of benefits and harms of cervical cancer screening. Methods: We used a cervical cancer natural history Markov model calibrated to the Canadian context to simulate 100,000 unvaccinated women over a lifetime of screening with either cytology every 3 years or human papillomavirus (HPV) testing every 5 years. We estimated the balance of benefits and harms attributable to screening using various metrics, including colposcopies/life-year gained, and net lifetime quality-adjusted life-years (QALY) gained, a measure integrating women's health preferences. We present the average (minimum-maximum) model predictions. Results: Cytology-based screening led to 1,319,854 screening tests, 30,395 colposcopies, 13,504 life-years gained over a lifetime, 98 screening tests/life-year gained, 2.3 (1.6-3.3) colposcopies/life-year gained, and a net lifetime gain of 10,735 QALY (5,040-17,797). HPV-based screening with cytology triage in the same population would lead to 698,250 screening tests, 73,296 colposcopies, 15,066 life-years gained over a lifetime, 46 screening tests/life-year gained, 4.9 colposcopies/life-year gained (2.9-11.1), and a net lifetime gain of 11,690 QALY (4,409-18,742). HPV-based screening was predicted to prevent more cancers, but also incur more screening harms than cytology-based screening. Conclusions: Metrics using colposcopies as the main harm outcome favored cytology-based screening, whereas metrics based on screening tests and health preferences tended to favor HPV-based screening strategies. [ABSTRACT FROM AUTHOR]

Published
2020
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50. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study.

Author

Bouchard, Céline, Labrie, Fernand, Derogatis, Leonard, Girard, Ginette, Ayotte, Normand, Gallagher, John, Cusan, Leonello, Archer, David F., Portman, David, Lavoie, Lyne, Beauregard, Adam, Côté, Isabelle, Martel, Céline, Vaillancourt, Mario, Balser, John, Moyneur, Erick, and other participating Members of the VVA Prasterone Group

Subjects
*DEHYDROEPIANDROSTERONE, *POSTMENOPAUSE, *ESTRADIOL, *TESTOSTERONE, *SEXUAL dysfunction, *VAGINA
Abstract

Objective: Intravaginal DHEA (dehydroepiandrosterone, prasterone), the exclusive precursor of androgens and estrogens in postmenopausal women, has previously been shown to improve all the domains of sexual function by a strictly local action in the vagina. The well recognized female sexual function index (FSFI) questionnaire was used in the present study. Design: The long-term effect of 52-week treatment with daily intravaginal 0.50% (6.5 mg) DHEA was evaluated on the various domains of female sexual function using the FSFI questionnaire at baseline, Week 26 and Week 52. Subjects: One hundred and fifty-four postmenopausal women with at least one mild to severe symptom of vulvovaginal atrophy (VVA) and who have completed the FSFI questionnaire at baseline and at least one post-baseline timepoint were included in the analysis. Results: The FSFI domains desire, arousal, lubrication, orgasm, satisfaction and pain were increased by 28%, 49%, 115%, 51%, 41% and 108%, respectively (p<0.0001 for all parameters) at 52 weeks vs. baseline, while the total score was increased from 13.4±0.62 at baseline to 21.5±0.82 (+60%, p<0.0001) at 52 weeks. Conclusion: As the serum levels of DHEA and all its metabolites, including estradiol and testosterone, show no meaningful change, the present clinical data indicate a stimulatory effect of intravaginal DHEA through a strictly local action in agreement with the preclinical data showing that the androgens made locally from DHEA in the vagina induce an increase in local nerve density. [ABSTRACT FROM AUTHOR]

Published
2016
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