Treatment Of Heavy Menstrual Bleeding Research Articles

RWD121 Baseline Characteristics of Patients Prior to Oriahnn Prescription

In July of 2020 Oriahnn was approved in the United States for the treatment of heavy menstrual bleeding (HMB) due to Uterine fibroids (UF). To date no studies have been published examining the use of Oriahnn in the real world. This study aims to describe the baseline characteristics the patient population being treated with Oriahnn.

Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis.

Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis.

Levonorgestrel-Releasing Intrauterine Device Use Can Be a Treatment Option in Symptomatic Patients with Isthmocele.

Levonorgestrel-releasing intrauterine devices have been used for contraception and treatment of heavy menstrual bleeding. There is only limited data about the effect of this on isthmocele. Here, we aimed to evaluate the effect of levonorgestrel-releasing intrauterine devices in a larger study population with a longer follow-up as compared to the literature on symptomatic patients with isthmocele. A total of 29 patients with symptomatic isthmocele and inserted levonorgestrel-releasing device were included in this prospective study. All patients were included at January 2020 and followed for 18months. Sociodemographic findings, laboratory parameters, premenstrual spotting, postmenstrual spotting, menorrhagia, dysmenorrhea, and pelvic pain related to isthmocele were recorded. In sonography, width, length, area of isthmocele, and residual myometrial thickness were determined. The frequency of symptoms during follow-up was compared between visits and also compared between groups according to residual myometrial thickness. Premenstrual spotting and pelvic pain were significantly reduced at 6th months (48.3 to 10.3%, p = 0.007 and 34.5 to 10.3%, p = 0.039, respectively) and no significant change was detected until the end of follow-up period. Postmenstrual spotting reduced at 6th months (96.6 to 34.5%, p < 0.001) and also significant change was detected between 6 and 12th months (34.5% vs 13.8%, p = 0.031). Menorrhagia and dysmenorrhea disappeared at 12th months. No association was found between residual myometrial thickness and the frequency of symptoms for each follow-up. Levonorgestrel-releasing intrauterine devices are useful and reliable therapeutic tools for symptomatic isthmocele patients who do not desire fertility, regardless of residual myometrial thickness.

Does a Bleeding Disorder Lessen the Efficacy of the 52-mg Levonorgestrel-Releasing Intrauterine System for Heavy Menstrual Bleeding in Adolescents? A Retrospective Multicenter Study

PurposeThe aim of this study is to compare the patient-reported bleeding outcomes and complication rates with the use of the 52-mg levonorgestrel-releasing intrauterine system (52-LNG-IUS) for treatment of heavy menstrual bleeding (HMB) among adolescents with and without a diagnosed inherited bleeding disorder (BD) within the first 12 months after insertion. MethodsRetrospective chart review was conducted of adolescents ages 14–21 years, with and without an inherited BD, who underwent 52-LNG-IUS insertion between September 2013 and February 2020 for the treatment of HMB. ResultsOne hundred forty-four 52-LNG-IUS insertions among 139 subjects were evaluated. Fifty-nine (41%) of these were among adolescents with a diagnosed inherited BD, and 85 (59%) were among those without a BD. Among subjects with follow-up, documentation of patient-reported bleeding outcome, and a retained IUS (92/144), both groups subjectively reported improvement in bleeding outcome, with 91.7% (33/36) of those with a BD and 94.6% (53/56) of those without a BD reporting that bleeding outcome was better than prior to IUS insertion (p = .675). There was no statistically significant difference in the rate of spontaneous expulsion (p = .233), with the rate of expulsion in the first 12 months after placement among those with a BD of 13.7% (7/51) and 6.8% for those without a BD (5/72). DiscussionAdolescents with HMB both with and without an inherited BD benefit from the 52-LNG-IUS for the treatment of HMB. Rates of spontaneous IUS expulsion are not statistically different regardless of the presence of a BD and are similar to rates found in other studies of intrauterine device use in adolescents.

Caregiver Knowledge of and Attitudes Toward the Levonorgestrel-Containing Intrauterine Device for the Treatment of Heavy Menstrual Bleeding in Adolescents and Young Adults.

We evaluated caretaker knowledge of and attitudes toward the levonorgestrel-containing intrauterine device (L-IUD) as a treatment option for adolescents and young adults with heavy menstrual bleeding. A survey assessed demographic characteristics, menstrual history, perception of the L-IUD, and knowledge of the indications, risks, and benefits of the L-IUD. Participant recruitment occurred in the offices of a pediatric gynecologist, pediatric hematologist, and adolescent medicine physician in a hospital-based practice in New York. English-speaking caretakers of patients with a chief concern of heavy menstrual bleeding (<21 years old) were invited to participate. Electronic and paper surveys were administered prior to seeing the physician. The primary outcome was participant willingness to allow their daughter to use the L-IUD for heavy menstrual bleeding. Additional outcomes were explored by calculating a mean knowledge score and conducting a descriptive analysis of the perception questions. Forty surveys were included. Seventy percent of participants said they would allow their daughter to use birth control pills for heavy menstrual bleeding, whereas only 10% said the same of the L-IUD. The mean knowledge score was 73.3% (±15.7). Sixty-five percent of participants expressed the need for additional information on the L-IUD. Caretaker acceptance of the L-IUD as treatment for their daughter with heavy menstrual bleeding is limited. Although baseline knowledge was high, many indicated needing additional information. Because heavy menstrual bleeding can negatively impact quality of life, potential caretaker bias must be addressed to ensure full access to this highly effective treatment option.

THE EFFECTS of HEAVY MENSTRUAL BLEEDING on SCHOOL and SOCIAL LIFE in NURSING and MIDWIFERY STUDENTS

This study was conducted to determine the effects of heavy menstrual bleeding (HMB) on school and social life in nursing and midwifery students. This sectional study was conducted with 416 female students studying at the nursing and midwifery section of the health-related university higher education institution. The data were collected with a questionnaire including 30 questions on the sociodemographic and menstrual features and the effects of HMB on school and social life. Descriptive statistics were used to evaluate the data while paired comparisons were performed with the chi-square test. The prevalence of HMB determined according to the criteria was found to be 40.6% There was a statistically significant relationship between the presence of HMB in the students and the level of the effect of menstrual bleeding on the physical activity, sleep, productivity at home, and the school, social, family and getting dressed living areas (p&lt;0.05). Those with HMB were found to experience more shortness of breath and sleeplessness, to limit their social activities, and to have difficulties concentrating and understanding the lectures compared to those without HMB; the school success, attendance, social relationships, daily activities, self-confidence, and choosing and using clothing were found to be affected in addition to avoidance of visiting places where a long stay during the day was likely (p&lt;0.05). We found that HMB was common in nursing and midwifery students and that it had a negative effect on the school and social areas along with many areas of their life. The students need to be made more aware of the diagnosis and treatment of HMB and guided so that they show health-seeking behavior in order to decrease the problems experienced in the school and social life areas.

Association between menorrhagia and risk of intrauterine device–related uterine perforation and device expulsion: results from the Association of Uterine Perforation and Expulsion of Intrauterine Device study

Intrauterine devices are effective instruments for contraception, and 1 levonorgestrel-releasing device is also indicated for the treatment of heavy menstrual bleeding (menorrhagia). To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the first 12 months before device insertion STUDY DESIGN: This was a retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (eg, levonorgestrel or copper) insertions from 2001 to 2018 and without a delivery in the previous 12 months were studied in this analysis. Recent menorrhagia diagnosis (ie, recorded ≤12 months before insertion) was ascertained from the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes. The study outcomes, viz, device expulsion and device-related uterine perforation (complete or partial), were ascertained from electronic medical records and validated in the data sources. The cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated the crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. Among 228,834 nonpostpartum women, the mean age was 33.1 years, 44.4% of them were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with a menorrhagia diagnosis had a higher intrauterine device-expulsion rate (40.01 vs 10.92 per 1000 person-years) than those without, especially evident in the first few months after insertion. Women with a menorrhagia diagnosis had a higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70-7.32] at 1 year and 12.03% [11.52-12.55] at 5 years) vs those without (1.77% [1.70-1.84] at 1 year and 3.69% [3.56-3.83] at 5 years). The risk of expulsion was increased for women with a menorrhagia diagnosis vs for those without (adjusted hazard ratio, 2.84 [95% confidence interval, 2.66-3.03]). The perforation rate was low overall (<1/1000 person-years) but higher in women with a diagnosis of menorrhagia vs in those without (0.98 vs 0.63 per 1000 person-years). The cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06-0.14] at 1 year and 0.39% [0.29-0.53] at 5 years) than those without it (0.07% [0.06-0.08] at 1 year and 0.28% [0.24-0.33] at 5 years). The risk of perforation was slightly increased in women with a menorrhagia diagnosis vs in those without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10-2.13). The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding the potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. The increased expulsion and perforation rates observed are likely because of causal factors of menorrhagia.

An evaluation of relugolix/estradiol/norethindrone acetate for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women

ABSTRACT Introduction Uterine Fibroids (UFs) are the most predominant benign tumor in women who are coming of reproductive age, and causes intense economic load priced in billions of US dollars. Historically, surgery has been the main definitive treatment, albeit less attractive nowadays, especially for women with future fertility plans. Therefore, studies to explore the pharmacological treatment options are increasing especially as those that are currently available are limited for short-term use only. Areas covered This drug evaluation features the clinical results from previous and ongoing studies of relugolix, in combination with the add back therapy of estradiol (E2) and norethindrone acetate (NETA), as a novel, orally administered, nonpeptide antagonist of gonadotropin-releasing hormone (GnRH) for the management of heavy menstrual bleeding (HMB) in premenopausal women with UFs. Expert opinion The combination of relugolix/E2/NETA is an encouraging, well-tolerated and noninvasive pharmacological option for UFs patients. Relugolix induced a concentration-dependent decrease in HMB. However, it should be used with hormonal add-back therapy (E2+ NETA) to avoid induced hypoestrogenic side effects, importantly bone mineral density loss. Moreover, symptoms will likely resume shortly after the termination of the relugolix combination administration.

Modified Thermal Balloon Endometrial Ablation for Treatment of Heavy Menstrual Bleeding.

Objectives:The objective of this study was to determine the efficacy of modified thermal balloon ablation using Foley's catheter in the treatment of heavy menstrual bleeding (HMB).Materials and Methods:Twelve patients with HMB aged 35–55 years underwent modified thermal balloon ablation using Foley's catheter. Patients were selected after complete clinical evaluation and investigations. The procedure was undertaken in the operation theater under general anesthesia/intravenous sedation. Three cycles of modified thermal balloon ablation using Foley's catheter were performed to ablate the endometrium. The time given to each cycle was 7 min. All the cycles were performed in the same setting. The main outcome measures that were studied were reduction in the menstrual flow, the need for further treatment, and relief of dysmenorrhea if present. Outcome measure regarding reduction in menstrual flow was statistically analyzed using Fisher's exact test. Statistical significance was determined at a level of P < 0.05.Results:Eighty-two percent of patients experienced a reasonable reduction in menstrual blood flow at 3-month follow-up. Eighteen percent observed no change in bleeding pattern and needed further treatment after failure of the procedure. Forty-two percent of patients complained of minor side effects such as cramp lower abdominal pain and fever. Rupture of balloon during the procedure occurred in only one case (8%).Conclusion:Modified thermal balloon ablation with Foley's catheter can be a promising management of HMB in resource-poor settings. It is a cost-effective alternative to the original endometrial ablation techniques.

Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding

Background: Heavy menstrual bleeding (HMB) poses threat to the quality of life among women. To prevent HMB, the levonorgestrel-releasing intrauterine system (LNG-IUS) is a well-known nonsurgical, long-performing, and alternative method. Objectives: The objective of this study was to determine the efficacy of LNG-IUS in women with HMB through an analytical observational study. Materials and Methods: This study was performed among 60 patients who visited the gynecology and obstetrics outpatient department (OPD) at the Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKMH), Kolkata, West Bengal, India from May 2019 to April 2020 due to HMB. The mean demographic and clinical profiles were evaluated, and comparative analysis was performed for hemoglobin (Hb), spotting, pain, and endometrial thickness on day 0 and follow-up 3 months, 6 months, and 12 months. Results: The mean age of patients was 37.77 ± 4.58 years was obtained. The Hb level was significantly (P &lt; .001) increased, whereas pictorial blood loss assessment chart (PBAC) score, endometrial thickness, spotting, and pain were significantly (P &lt; .01 and P &lt; .001) reduced. The majority of patients had pallor, but the rates of spontaneous expulsion and hysterectomy were observed lower after using LNG-IUS among studied patients. Conclusion: the usage of LNG-IUS is potential in the treatment of HMB in women, which may lead to a better quality of life. This can be the alternative to hysterectomy and oral pills for long-term use. It is suggested in a future study with larger sample size and multicentric approach to minimize hospital biasness.

Mirena: Just a contraceptive device? or A modality with diverse clinical applications !

Abnormal uterine bleeding is the most frequently encountered complaint of the reproductive-age women. Heavy menstrual blood loss is responsible for interfering with women's physical, emotional, social, and quality of life. Levonorgestrel-releasing intrauterine device (LNG-IUS) is a highly effective reversible form of contraception. Besides this, its role in the treatment of heavy menstrual bleeding (HMB), endometrial hyperplasia, early-stage endometrial cancers, and endometrial protection as a part of hormone replacement therapy (HRT) is very well studied. This review will revisit the role of LNG-IUS as a nonsurgical option in the management of HMB.

Эффективность и безопасность комбинированного контрацептива с хлормадинона ацетатом при обильных менструальных кровотечениях и дисменорее в реальной клинической практике

This article presents the results of the prospective study involving 70 patients of reproductive age with heavy menstrual bleeding (HMB) and dysmenorrhea, interested in reliable contraception. Objective. To study the safety and efficacy of the low-dose combined oral contraceptive (COC) containing chlormadinone acetate (CMA) for the treatment of dysmenorrhea and HMB in real clinical practice. Patients and methods. Among 90 women who sought a method of contraception, we identified a group of 70 patients aged 18–45 years (mean age = 31.0 ± 7.7 [95% CI 29.2–32.9]) with complaints for HMB (n = 23) and/or dysmenorrhea (n = 65): primary (n = 37) and secondary (n = 28). For contraception, COC containing 0.03 mg ethinyl estradiol and 2 mg CMA was recommended. After 3 months, the dynamics of the volume of menstrual blood loss, pain severity (according to the Numeric Rating Scale (NRS)), as well as the frequency of side effects were assessed. Results. Among 90 women of reproductive age, 70 (78%) had HMB and/or dysmenorrhea of varying severity. After 3 months of using a low-dose CMA-containing COC, 87% of patients with HMB showed a statistically significant decrease in menstrual blood loss (p &lt; 0.001); in 72% of patients, a significant decrease in pain severity was observed: mean NRS value before taking COC was 6.2 ± 2.1 [95% CI 5.7–6.7]), it decreased to 3.5 ± 1.8 [95% CI 3.0-3.9]) (p &lt; 0.001) after 3 months. There were no significant differences in efficacy between the groups with primary and secondary dysmenorrhea. Conclusion. The prevalence of HMB and dysmenorrhea in a random sample of women of reproductive age is consistent with the data of systematic reviews (26% and 72%, respectively). The results obtained in real clinical practice confirm the additional therapeutic efficacy of the low-dose CMA-containing COC in HMB and dysmenorrhea. The frequency and severity of side effects during the COC use do not depend on the initial body mass index, but with an increase in the waist-to-hip ratio, there is a tendency to reduce the chance of developing side effects of using COC, which corresponds to the data on the metabolic neutrality of chlormadinone. Key words: chlormadinone, heavy menstrual bleeding, dysmenorrhea

Hysteroscopic Endometrial Resection Sterilization (HERS): Complete Endometrial Resection for Permanent Transcervical Sterilization

<h3>Study Objective</h3> To discuss the concept of hysteroscopic complete resection of the endometrium for permanent transcervical sterilization. <h3>Design</h3> Retrospective review for women ≤ 45 undergoing complete resection of the endometrium. <h3>Setting</h3> Minimally Invasive Gynecologic Surgery private practice. <h3>Patients or Participants</h3> Endometrial resection ablation (ERA) has been offered as a treatment for heavy menstrual bleeding (HMB) at AWHI since 1994. It became apparent ERA results in complete obliteration of the cavity after myometrial fusion, which takes 4-6 months. As a result, women were counseled they could rely on ERA for permanent sterilization after that time. We have offered HERS to women without HMB for over 20 years. <h3>Interventions</h3> Complete resection of the endometrium to 6-8 mm myometrial depth using an operative hysteroscope and wire resecting loop, from interstitial portion of tubes to mid-cervical canal. Many, but not all patients were pretreated to reduce endometrial thickness. <h3>Measurements and Main Results</h3> The AWHI database was queried and 356 patients were identified. It is assumed an unanticipated pregnancy following ERA would be reported, since litigation would likely ensue. To date, no pregnancies have been recorded. <h3>Conclusion</h3> ERA is an established procedure for HMB which results in complete obliteration of the cavity and amenorrhea with no foreign body left in place. HERS can be offered to women without HMB for permanent transcervical sterilization.

The Cerene Cryoablation Device for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the Clarity Study

<h3>Study Objective</h3> To evaluate the safety and effectiveness of a novel cryoablation device (<i>Cerene Cryotherapy Device, Channel Medsystems, Berkeley, CA)</i> in premenopausal women with heavy menstrual bleeding (HMB) due to benign causes. <h3>Design</h3> A prospective, multi-center, single-arm, open-label study. <h3>Setting</h3> 8 sites in the USA, 1 in Mexico, 2 in Canada. <h3>Patients or Participants</h3> 242 Intent-to-Treat women, 25 to 50 years of age, with HMB, uterine sound ≤10 cm, and endometrial cavity between 2.5 to 6.5 cm. <h3>Interventions</h3> The Cerene single-use disposable device, delivered a 2.5-minute cryoablation of the endometrium. Analgesia and local anesthesia were administered per investigator discretion: 97% of subjects received a paracervical block with or without oral medications, 3% IV sedation, and none received general anesthesia. 180 USA treatments were performed in the physician office setting and none in the operating room. Subjects were evaluated through Month 12 and long term at Month 24 and 36. <h3>Measurements and Main Results</h3> 201 women were evaluated at Month 36. 88.6% (178/201) reported amenorrhea, a lighter than normal, or normal period. 91% (182/201) reported no or slight limitations in life activities in their Menorrhagia Impact Quality of Life (QoL) questionnaire. 85% (171/201) reported premenstrual symptoms (PMS) at a low frequency (none, rarely, or sometimes) in their PMS Impact QoL Survey. 84.5% (153/181) of subjects who reported level of satisfaction at the final study visit stated that they were satisfied or very satisfied with their treatment outcome. 7% (17/242) underwent a post ablation intervention for menstrual bleeding. <h3>Conclusion</h3> The Cerene endometrial cryoablation device maintains safety and effectiveness for the treatment of HMB through the long-term study visit at 36 months. It is a global endometrial ablation technique that can be performed consistently in the office setting requiring minimal anesthesia or analgesia.

Key issues in the management of adolescents and young women with heavy menstrual bleeding

Despite high prevalence of heavy menstrual bleeding (HMB) in adolescents and young women, most recommendations are not specific for this population, which makes the diagnosis and management challenging. Gynecologists should be able to establish underlying causes of HMB, which most common are nonstructural in adolescents, and the severity of bleeding, to provide early diagnosis, using appropriate therapy for improving quality of life and iron deficiency prevention. First line management consists of hormonal therapy approved for HMB treatment, capable to normalize menstrual blood loss and iron metabolism parameters.

Prevalence, burden and treatment effects of vaginal bleeding in women with (suspected) congenital platelet disorders throughout life: a cross-sectional study.

SummaryCongenital platelet disorders (CPDs) are rare bleeding disorders that are associated with mucocutaneous bleeds. However, data on vaginal bleeding in women with CPDs are scarce. A set of generic and bleeding‐specific questionnaires were used to evaluate the prevalence of vaginal bleeding, its impact on quality of life (QoL) and sexual functioning and the consequences for pregnancy, miscarriage and delivery in a cohort of women who were referred for diagnostic evaluation for CPDs. A total of 78 women included in the study were either diagnosed with a CPD (n = 35) or were clinically suspected of a CPD (n = 43). Heavy menstrual bleeding (HMB) was reported by a large proportion of women, which mainly started at menarche. In all, 76% of women received any kind of HMB treatment, often leading to surgical prodecures. HMB was shown to have a high impact on QoL, which improved upon treatment. Even though women reported that vaginal bleeding affects sexuality, this topic is not frequently discussed with physicians. Heavy blood loss frequently occurred after miscarriage/delivery, often requiring treatment. Women with (suspected) CPDs frequently encounter HMB, negatively impacting daily life and sexual functioning. Together with peripartum bleeding, these data highlight the burden of vaginal bleeding in CPDs and importance of adequate treatment.

The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: A systematic review.

Despite endometrial ablation/resection being a very successful treatment for women with heavy menstrual bleeding, re-intervention with additional surgery is needed in 12%-25% of cases. Introducing a levonorgestrel-intrauterine system (LNG-IUS) immediately after ablation could preserve the integrity of the uterine cavity and suppress the regenerated or non-ablated endometrial tissue. Therefore, this combined treatment can perhaps lower the re-intervention rate. The aim of this systematic review was to assess the impact of the combined treatment. The MEDLINE, EMBASE, and Cochrane library were systematically searched. No language restrictions were applied. All types of studies were included reporting on the results of endometrial ablation or resection combined with immediate insertion of LNG-IUS for treatment of heavy menstrual bleeding. The primary outcome was the number of hysterectomies after the ablation procedure. Secondary outcomes included re-intervention rates, removals of LNG-IUS, bleeding pattern, patient satisfaction, adverse effects, and complications. Our protocol was registered in PROSPERO, an international prospective register of systematic reviews under registration number CRD42020151384. Six studies with a retrospective design and one case series with a follow-up duration varying from 6 to 55months were included. In total, 427 women were treated with the combined treatment. The studies described a lower hysterectomy and re-intervention rate after combined treatment compared with treatment with endometrial ablation/resection alone. Hysterectomy rate varied from 0% to 11% after combined treatment compared with 9.4% to 24% after endometrial ablation/resection alone. Bleeding patterns and patient satisfaction appeared to be in favor of the combined treatment group. No intra- or post-operative complications or complications in the removal of LNG-IUS were described. The most reported adverse effects after combined treatment were weight gain, mood changes, and headaches. An additional 11 studies with only an abstract available substantiated these findings. All the included studies had poor methodological quality. Based on the available literature, inserting an LNG-IUS immediately after endometrial ablation/resection seems to lower the hysterectomy and re-intervention rates compared with ablation/resection alone. However, as only limited observational studies of low methodological quality are available, high-quality research is necessary to confirm the findings of this systematic review.

Comparison of two levonorgestrel-releasing intrauterine systems for the treatment of heavy menstrual bleeding: a randomised, controlled, phase 3 trial

Purpose To evaluate the levonorgestrel-releasing intrauterine system Donasert® (also known as Levosert®) compared with the reference product Mirena® for the alleviation of heavy menstrual bleeding (HMB). Materials and methods A phase 3 multicentre, non-inferiority, active-controlled study in non-menopausal women with HMB (menstrual blood loss [MBL] ≥ 80 mL) as the primary symptom randomised to either Donasert® or Mirena® and followed for 6 months. MBL was evaluated using a validated, modified version of the Wyatt pictogram. Results Overall, 312 were randomised (158 to Donasert® and 154 to Mirena®). The mean (standard deviation) absolute change in MBL from baseline to 6 months in the per-protocol population (N = 300) was −130 (71.8) mL and −127 (67.3) mL in the Donasert® and Mirena® groups, respectively; non-inferiority of Donasert® was confirmed (p-value <0.0001). Successful treatment of HMB (MBL <80 mL) and a decrease to ≤50% of baseline MBL was achieved in 139/154 (90.3%) and 126/146 (86.3%) participants in the Donasert® and Mirena® groups, respectively and the between-treatment difference was non-significant. Most adverse events were mild in severity. Only two device expulsions occurred in the study and there were no uterine perforations. Conclusions Donasert® has equivalent efficacy and safety during the first 6 months foralleviation of HMB compared to the reference device, Mirena®. Trial registration number 348 (Clinical Trials Registry of the Ministry of Health of the Russian Federation, http://grls.rosminzdrav.ru/default.aspx)

Pain scores at the insertion of the 52 MG levonorgestrel-releasing intrauterine system among nulligravidas and parous women

Purpose This study aimed to assess the pain scores at the insertion of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) among nulligravidas, parous women with previous vaginal delivery and parous women with elective caesarean-delivery without any previous labour or cervix dilation. Materials and methods The present research is a prospective, single-cohort study that included 413 women aged 15–49 years who opted for LNG-IUS placement for contraception or treatment of heavy menstrual bleeding. Women who participated in the present study were not submitted to any pharmacological pain-relieving intervention to perform the procedure. Pain at insertion was evaluated by using a Visual Analogue Scale (VAS). Pain was classified as absent (0), mild (1–3), moderate (4–6), or severe (7–10). The women were divided as: (1) nulligravidas, (2) parous women with a previous vaginal delivery, or (3) parous women with elective caesarean-delivery without any previous labour or cervix dilation. Results Nulligravidas women presented a higher mean pain score, when compared to women with elective caesarean-delivery and women with previous vaginal delivery (6.6 ± 2.0 vs 5.5 ± 2.1 and 3.9 ± 2.4, respectively; p < 0.001). Nulligravidas and women with elective caesarean-delivery were more likely to have pain classified as moderate or severe (in relation to absent or mild) than women with previous vaginal delivery (p < 0.001). Multiple Linear Regression Analysis demonstrated that 29.5% of all variability of the pain score was explained by two predictor/independent variables: nulligravidas or women with elective caesarean and difficulty at IUD insertion. Conclusions Women with previous vaginal delivery had lower pain scores at LNG-IUS insertion when compared to nulligravidas and women with elective caesarean-delivery without any previous labour.

Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids.

To review data of elagolix plus estradiol and norethindrone acetate as add-back therapy for the treatment of heavy menstrual bleeding (HMB) in premenopausal women with uterine fibroids. Literature search of PubMed/MEDLINE and SCOPUS was performed using the search terms Oriahnn; elagolix, estradiol, norethindrone AND heavy menstrual bleeding; elagolix AND heavy menstrual bleeding; and gonadotropin-releasing hormone receptor antagonist AND heavy menstrual bleeding between January 1, 1996, to March 2, 2021. Additional data were obtained from prescribing information, references of identified articles, and abstracts from scientific meetings. Clinical trials and articles discussing elagolix plus add-back therapy for the management of HMB in women with leiomyomas were included. Phase 3 trials met the primary end point of menstrual blood loss (MBL) less than 80 mL at month 6 and at least a 50% reduction in MBL from baseline to the final month in 68.5% of women taking elagolix plus add-back therapy enrolled in UF-1 (8.7% placebo) and 76.5% of women in UF-2 (10% placebo). The most common adverse effects include hot flushes, nausea, headache, and night sweats. Women with symptomatic uterine fibroids can experience significant HMB resulting in distress, depression, and anxiety. Surgical intervention remains the most commonly recommended and chosen treatment. Elagolix plus add-back therapy is a nonsurgical, oral option. Elagolix plus add-back therapy is effective in reducing menstrual bleeding associated with uterine fibroids. However, there are several warnings and precautions that must be considered.