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Background: Requests for assistance in menstrual management and menstrual suppression are a common, emotive and sometimes controversial aspect of adolescent disability care., Aims: To review the uptake and outcomes of menstrual suppression among adolescent patients with developmental delay., Methods: A retrospective review of the medical records of adolescent females with intellectual disability referred for menstrual management to the Paediatric and Adolescent Gynaecology Clinic, Children's Hospital at Westmead, Sydney, for the three-year period between January 1, 2010 and January 1, 2013., Results: Eighty adolescent patients with developmental delay were identified. A third (n = 28) of the patients were pre-menarcheal at first review with parent/caregivers seeking anticipatory advice. Of the post-menarcheal patients, the median age of menarche was 12 years (range 10-15 years). First and second line interventions were documented as were reasons for change where applicable. The combined oral contraceptive pill (COCP) was the most frequently used therapy (67%), and 19 patients in total had a levonorgestrel releasing intrauterine system (LNG-IUS) inserted (31%). Our study population differs from similar previously published groups in the marked absence of the use of depot medroxyprogesterone acetate or the subdermal etonogestrel releasing device., Conclusion: As a paediatrician, it is important to address menstrual management issues and allay caregiver concerns with appropriate advice. Our study supports the use of the COCP as sound first line management in achieving menstrual suppression. The LNG-IUS appears to be a favourable second line option. Further investigation into longer-term outcomes and potential complications of device insertion is recommended., (© 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background: Abnormal uterine bleeding is defined as any alteration in the pattern or volume of menstrual blood flow, and it is preferably treated using hysterectomy, endometrial destruction or the levonorgestrel-releasing intrauterine system (Mirena(®) ). Recently, it has been demonstrated that studies of Mirena(®) were generally small and consequently imprecise., Aims: Our study was aimed at assessing the effects of a slow-release levonorgestrel (20 μg/day) intrauterine device in fertile and postmenopausal women experiencing abnormal uterine bleeding that did not respond to traditional medical management., Materials and Methods: A total of 40 women, of whom 24 were of reproductive capacity and 16 were postmenopausal, were enrolled in the trial. Removal of the intrauterine device was required for only 2 of the 24 fertile women and for only 3 of the 16 postmenopausal women. After 6 and 12 months of treatment, the remaining women were clinically evaluated and underwent ultrasound and hysteroscopy using biopsy specimens as a control. The EuroQol Group EQ-5D questionnaire was used for evaluation of quality of life., Results: The device showed good tolerability and efficacy. It resulted in a reduction in the endometrial mucosal thickness with a regression of bleeding and collateral effects, which were more evident after 12 months of treatment. A positive effect of the device on the woman's quality of life was demonstrated., Conclusions: The slow-release levonorgestrel intrauterine device may be a valid therapeutic tool for treating basic symptomatology and increasing quality of life in women with abnormal uterine bleeding., (© 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Objective: To assess the efficacy of tranexamic acid or mefenamic acid in the management of the initial "nuisance" bleeding or spotting in the period immediately after placement of the levonorgestrel-releasing intrauterine system., Methods: Women were randomized after levonorgestrel-releasing intrauterine system placement to oral tranexamic acid (500 mg), mefenamic acid (500 mg), or placebo three times daily during bleeding or spotting episodes over a 90-day treatment period. Treatment was initiated from onset of a bleeding or spotting episode and continued until the first day after bleeding or spotting stopped and restarted with a new bleeding or spotting episode. The primary efficacy variable was reduction in the number of bleeding or spotting days. Tranexamic acid and mefenamic acid were compared with placebo using a one-sided Wilcoxon rank-sum test. Bonferroni-Holm adjustment was used to account for multiple testing., Results: A total of 204 women were screened; 187 were randomized to tranexamic acid (n=63), mefenamic acid (n=63), or placebo (n=61). The median number of bleeding or spotting days experienced during treatment was 25, 29, and 33 days in the three groups, respectively. The median number of bleeding or spotting days was reduced by 6 days (95% confidence interval [CI] -14.0 to 1.0, P=.049) with tranexamic acid and by 3 days (95% CI -11.0 to 5.0, P=.229) with mefenamic acid compared with placebo. The relative risk of bleeding or spotting compared with placebo with tranexamic acid and mefenamic acid was 0.82 (95% CI 0.65-1.03) and 0.89 (95% CI 0.71-1.11), respectively. Most women (85% or more) were satisfied with the levonorgestrel-releasing intrauterine system across the groups., Conclusions: Tranexamic acid and mefenamic acid during the first 90 days after levonorgestrel-releasing intrauterine system placement do not alleviate "nuisance" bleeding or spotting., Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01295294., Level of Evidence: I.

Objective: Endometrial hyperplasia is clinically important, because it can lead to abnormal uterine bleeding (AUB) which itself can precede endometrial cancer. Endometrial carcinoma is the most common malignancy of the female genital tract, occurring in about 75%-85% younger, perimenopausal women as endometrial hyperplasia. The treatment is hysterectomy or hormone therapy with progesterone. The aim of this study was, therefore, to compare the effect of levonorgestrel intrauterine device (LNG-IUD) with medroxyprogesterone acetate (MPA) on simple endometrial hyperplasia for fertility preservation., Materials and Methods: Forty women in reproductive age (22-47 years) with AUB with endometrial biopsies confirming simple hyperplasia, were enrolled in this study and then randomly divided into two groups. All patients presented with designed special checklist which was filled with satisfaction. Complete history and physical examination especially blood pressure (BP), body mass index (BMI), breast examination, bimanual vaginal examination, and transvaginal sonography (to measure the thickness of endometrial and exclude the other pathologic lesions) were performed. In the first group, treatment was performed with MPA (20 mg/daily) for ten days and in other group with LNG-IUD was prescribed. After three months, transvaginal sonography and biopsy of endometrium were done. The status of AUB and side-effects of two methods,along with the rate of satisfactory were evaluated., Result: The findings showed the significant differences in the treatment of simple hyperplasia between two groups (LNG-IUD group vs. MPA group) (p < 0.047). Recovery of AUB in the group LNG was enhanced (p < 0.047). Endometrial thickness was reduced in both groups (p < 0.001), but further reduction in LNG group was seen. Also, LNG was tolerated more than MPA. Side-effects of MPA were more and reached significance (p < 0.003). The rate of satisfaction with LNG was higher than MPA and reached significance (p < 0.048)., Conclusion: The results of this study show that LNG-IUD is more effective than MPA in treatment of simple endometrial hyperplasia and can be helpful in young women who want to preserve their fertilities.

Introduction: Heavy menstrual bleeding (HMB) and the spotting and bleeding (S/B) associated with the use of hormonal contraceptives are distinct entities affecting endometrial vasculature and hemostasis., Materials and Methods: An overview of the major etiologies and potential treatments for each condition is provided., Results: HMB is potentially caused by several different hemostatic dysfunctions. Combination oral contraceptives, levonorgestrel-releasing intrauterine system, non-steroidal anti-inflammatory drugs, and anti-fibrinolytics all have been shown to have some degree of efficacy in treating HMB. The basic cause of HMB is unknown in the majority of cases. Endometrial S/B related to hormonal contraceptives is a common occurrence and may well have a common etiology in altered angiogenesis resulting in abnormal blood vessels with fragile vessel walls. There is no effective treatment for this problem., Conclusions: Medical therapy for HMB is limited and effective for reducing blood loss during menstruation. There is no effective treatment for the S/B associated with hormonal contraceptives.

Evaluation of: Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, Phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil. Steril. 97(3), 616-622.e3 (2012). A randomized, open-label, Phase II study was conducted in 37 centers in five European countries to assess the optimal dose for a new contraceptive levonorgestrel intrauterine system (LNG-IUS). Overall, 742 parous or nulliparous women aged 21-40 years were allocated to receive a LNG-IUS that initially releases 12 µg/day (LNG-IUS(12)) or 16 µg/day (LNG-IUS(16)) in vitro or the currently available device that releases 20 µg/day (LNG-IUS(20)). The two new devices are shorter than the current one. Pearl Indices of 0.17, 0.82 and 0.00 for the LNG-IUS(12), LNG-IUS(16) and LNG-IUS(20), respectively, reflect the contraceptive efficacy of these devices. The mean number of bleeding and spotting days decreased in all three groups; however, this decrease was more significant in LNG-IUS(20) users. Placement of the new shorter devices was considered simple by providers, while patients reported significantly less pain with the two new devices compared with the current one. This study provided further insight into the development of two new LNG-IUS devices as contraceptives, with the additional possibility of using them to treat heavy menstrual bleeding or as endometrial protection during estrogen therapy.

Background: Unscheduled bleeding is the main side effect of continuous oral contraceptive pills (OCPs) and has been correlated with the up-regulation of matrix metalloprotineases (MMPs). The study objective was to determine if prophylactic administration of doxycycline (an MMP inhibitor at low subantimicrobial doses) would prevent unscheduled bleeding during the initiation of a continuous OCP., Study Design: Subjects using cyclic hormonal contraceptives (combined OCPs, patch or ring) without unscheduled bleeding were switched to continuous OCPs (20 mcg ethinyl estradiol/100 mcg levonorgestrel). They were randomized to receive daily doxycycline [sustained-release subantimicrobial dose (40 mg daily)] or placebo for the first 84 days and then observed for an additional 28 days on the continuous OCP alone. The number of bleeding/spotting days and the time in days it took to achieve amenorrhea were compared using a t test., Results: Sixty-five subjects were randomized. Although the use of doxycycline did not significantly decrease the number of mean bleeding/spotting days in the first 84 days of the study [doxycycline 14.75 (SE 2.30), placebo 17.78 (2.31), p=.36], women who received doxycycline had a significantly earlier onset of amenorrhea [mean last day of bleeding/spotting doxycycline 61.7 (7.7), placebo 85.2 (6.7), p=.03]., Conclusion: The coadministration of subantimicrobial-dose doxycycline during initiation of continuous OCPs results in a significant reduction in the length of time needed to achieve amenorrhea., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system., Study Design: We conducted a randomized controlled trial of naproxen, estradiol, or placebo that was administered over the first 12 weeks of levonorgestrel-releasing intrauterine system use. Participants completed a written bleeding diary. We imputed missing values and performed an intention-to-treat analysis., Results: There were 129 women who were assigned randomly to naproxen (n = 42 women), estradiol (n = 44 women), or placebo (n = 43 women). The naproxen group was more likely to be in the lowest quartile of bleeding and spotting days compared with placebo (42.9% vs 16.3%; P = .03). In the multivariable analysis, the naproxen group had a 10% reduction in bleeding and spotting days (adjusted relative risk, 0.90; 95% confidence interval, 0.84-0.97) compared with placebo. More frequent bleeding and spotting was observed in the estradiol group (adjusted relative risk, 1.25; 95% confidence interval, 1.17-1.34)., Conclusion: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Objective: To review the literature for economic and health-related quality of life outcomes data associated with the use of the levonorgestrel-releasing intrauterine system (LNG-IUS) in the management of heavy menstrual bleeding., Methods: We searched the MEDLINE and EMBASE databases simultaneously using the Ovid interface to review the literature in a systematic manner for economic and health-related quality of life outcomes data associated with the use of the LNG-IUS in women with heavy menstrual bleeding. Articles were then selected for further review based on the relevance of their titles and/or abstracts. We identified 17 articles for inclusion in this review., Results: Treating heavy menstrual bleeding with the LNG-IUS was found to be cost-effective in various countries and settings. Moreover, irrespective of the measuring instrument used, health-related quality-of-life outcomes were found to be improved to a degree similar to that achieved with endometrial ablation or hysterectomy. In some cases, the LNG-IUS appeared to be more effective and less costly than the surgical options., Conclusion: The LNG-IUS is a cost-effective treatment option for heavy menstrual bleeding when pharmacologic treatment is indicated., (Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Objective: To compare the cost and effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) versus combined oral contraception (COC) and progestogens (PROG) in first-line treatment of dysfunctional uterine bleeding (DUB) in Spain., Study Design: A cost-effectiveness and cost-utility analysis of LNG-IUS, COC and PROG was carried out using a Markov model based on clinical data from the literature and expert opinion. The population studied were women with a previous diagnosis of idiopathic heavy menstrual bleeding. The analysis was performed from the National Health System perspective, discounting both costs and future effects at 3%. In addition, a sensitivity analysis (univariate and probabilistic) was conducted., Results: The results show that the greater efficacy of LNG-IUS translates into a gain of 1.92 and 3.89 symptom-free months (SFM) after six months of treatment versus COC and PROG, respectively (which represents an increase of 33% and 60% of symptom-free time). Regarding costs, LNG-IUS produces savings of € 174.2-309.95 and € 230.54-577.61 versus COC and PROG, respectively, after 6 months-5 years. Apart from cost savings and gains in SFM, quality-adjusted life months (QALM) are also favourable to LNG-IUS in all scenarios, with a range of gains between 1 and 2 QALM compared to COC and PROG., Conclusions: The results indicate that first-line use of the LNG-IUS is the dominant therapeutic option (less costly and more effective) in comparison with first-line use of COC or PROG for the treatment of DUB in Spain. LNG-IUS as first line is also the option that provides greatest health-related quality of life to patients., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate the efficacy of mifepristone to reduce intermenstrual bleeding in levonorgestrel intrauterine system (LNG-IUS) users., Method: In this prospective, open-label, comparative study, 36 women using the LNG-IUS for menorrhagia received 100mg of mifepristone every 30 days for 3 months (group 1). Fifty age-matched LNG-IUS users who did not receive any drugs were used as the comparison group (group 2). Menstrual bleeding days, pictorial blood loss assessment chart (PBAC) score, and intermenstrual bleeding/spotting days were compared between the 2 groups at 3 months (during treatment) and at 6 months (3 months post treatment)., Results: Baseline characteristics were comparable between the groups. At 3 months, median duration and episodes of intermenstrual bleeding/spotting were significantly lower in group 1 compared with group 2 (6 vs 12.5 days, P=0.01; 2.5 vs 3, P=0.05, respectively). More women were satisfied with the LNG-IUS in the mifepristone group compared with the control group (75% vs 44%; P=0.004). At 6 months, the median duration of intermenstrual bleeding/spotting was significantly lower in group 1 compared with group 2 (6 vs 15 days; P=0.008)., Conclusion: Mifepristone was effective in reducing the number of episodes and duration of intermenstrual bleeding/spotting in LNG-IUS users., (Copyright 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate the efficacy of levonorgestrel intrauterine systems (LNG-IUS) in obese women with AUB on anticoagulant therapy., Design: Prospective observational case series (Canadian Task Force Classification II-3)., Setting: University affiliated teaching hospital., Patients: Premenopausal women on Warfarin therapy., Interventions: From January 2002 through January 2007, 10 women were identified from the senior author's clinical practice (G.A.V.). After clinical assessment, including Papanicolaou smear, endometrial biopsy, and pelvic sonography, the LNG-IUS was placed to treat their AUB., Measurements and Main Results: The median and range of age, parity, and body mass index were 45 years (34-49), 1 (0-4), and 38 kg/m(2) (26-52), respectively. All women were receiving warfarin therapy (4-12.5 mg/d) for previous venous thromboembolism. Some patients had additional comorbid conditions and were at high risk for traditional medical or surgical therapies. After placement of the LNG-IUS, all women reported menstrual reduction at 3 and 6 months. By 12 months, 1 woman with large fibroids expelled the LNG-IUS and was treated with transfemoral uterine artery embolization. Two women had amenorrhea, and 7 had hypomenorrhea. At 2 to 5 years, 1 woman expelled the LNG-IUS and hysterectomy indicated extensive adenomyosis in a 195-g uterus, and 1 woman had hysteroscopic endometrial ablation, 4 were menopausal, 2 had amenorrhea, and 1 had hypomenorrhea. In the 5 women with uterine fibroids measuring 4.2 to 147 cm(3), the fibroids were reduced in volume by approximately 75% in 2, were no longer detectable in 1, were subsequently shown to be adenomyoma in 1, and required uterine artery embolization in 1., Conclusion: In properly assessed and selected obese, premenopausal women with AUB receiving warfarin therapy and at high risk for traditional therapies, the LNG-IUS was an effective treatment in 70% of patients.

Background: Endometrial spotting and/or bleeding (ESB) occurs in levonorgestrel subcutaneous implant (LNG SI) users. Matrix metalloproteinases (MMPs) may play a role in ESB., Study Design: Women between 18 and 40 years with regular menstrual cycles had a baseline evaluation followed by LNG SI insertion and randomization to doxycycline (DOX; 20 mg) or placebo (PL) twice a day. MMP-2, MMP-9 and tissue inhibitor of MMP-1 (TIMP-1) in serum and the endometrium were estimated at baseline and at 1, 3 and 6 months after insertion., Results: LNG increased serum MMP-9, while DOX decreased MMP-9 levels compared to PL after 1 month (p<.05). DOX decreased endometrial MMP-9 at 1 and 6 months compared to baseline and PL (p<.05). DOX increased endometrial TIMP-1 at 6 months compared with baseline and PL (p<.05). MMP-2 levels were unchanged., Conclusion: LNG SI increased serum MMP-9 and TIMP-1 levels, while DOX decreased both serum and endometrial MMP-9 levels.

Study Objective: The purpose of this study was to estimate the influence of alternatives to hysterectomy for abnormal uterine bleeding (AUB) on hysterectomy rates., Design: Retrospective cohort study. Canadian Task Force II-2., Setting: University hospital., Patients: Premenopausal patients with AUB., Interventions: Medical records of all premenopausal patients treated for AUB in our university clinic between January 1, 1995, and December 31, 2004, were reviewed. Patients were identified based on (specific) diagnostic and therapy codes used in the registry system of the hospital. The total number of placements of levonorgestrel-releasing intrauterine device (LNG-IUD), hysteroscopic surgery, and hysterectomies performed/year was estimated. In addition, the course of treatment of each patient was assessed., Measurements and Main Results: A total of 640 patients received surgery and 246 LNG-IUDs were placed. The proportion of endometrial ablations decreased significantly over time (p <.001), whereas hysteroscopic polyp or myoma removal (p =.030) and insertion of LNG-IUD (p <.001) both increased. The proportion of patients receiving hysterectomy for AUB as their first therapy decreased significantly (p =.005) from 40.6% to 31.4%, although the total number of patients receiving hysterectomy remained similar (p =.449). The 5-year intervention-free percentage for LNG-IUD was 70.6% (SD = 3.3%), for hysteroscopic polyp or myoma removal 75.5% (SD = 3.3%), and for endometrial ablation 78.0% (SD = 4.3%; p =.067)., Conclusion: Despite the introduction of alternative therapies, the total hysterectomy rate in the management of AUB did not decrease in our clinic.

Objective: To compare the acceptability, efficacy, adverse effects, and user satisfaction of a levonorgestrel intrauterine system (LNG-IUS) and transcervical resection of the endometrium (TCRE) for the treatment of dysfunctional uterine bleeding., Method: Of 50 women with a pictoral blood loss assessment chart (PBAC) score of 100 or greater, 25 had a LNG-IUS inserted (Mirena; Schering, Berlin, Germany) and 25 underwent TCRE. Procedure-related complications, PBAC score, hemoglobin levels, adverse effects, and rates of acceptability and satisfaction were recorded at 3-month intervals for a period of 12 months., Results: At the end of 1 year there were a 97% and a 94% reduction in menstrual blood loss in the LNG-IUS and TCRE groups, respectively, and hemoglobin concentration had increased by 5.5% in the LNG-IUS group and 5.2% in the TCRE group. Adverse effects were similar in both groups except for systemic effects, which were seen only in the LNG-IUS group. Satisfaction rates were about 80% in the 2 groups., Conclusion: Both treatments were found to be equally effective but LNG-IUS placement requires less operator skill and entails no operative hazards, and the device provides effective contraception.