Repeated two cycles of ulipristal acetate treatment improve the quality of life in premenopausal women with heavy menstrual bleeding dependent on uterine myomas, without impairment of bone health

2019 ◽  
Vol 35 (9) ◽  
pp. 756-761 ◽  
Author(s):  
Manuela Neri ◽  
Monica Pilloni ◽  
Anna Maria Paoletti ◽  
Gian Benedetto Melis ◽  
Bruno Piras ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bone Health ◽  
Premenopausal Women ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding ◽  
Ulipristal Acetate ◽  
Uterine Myomas

O-135 Long term secondary efficacy of linzagolix for heavy menstrual bleeding (HMB) due to uterine fibroids (UF): 52-week results from two placebo-controlled, randomized, phase 3 trials

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
H Taylor ◽  
J Donnez ◽  
F Petraglia ◽  
K Gemzell Danielsson ◽  
S Renner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Score ◽  
Uterine Fibroids ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding ◽  
Phase 3 ◽  
Once Daily ◽  
Secondary Endpoints

Abstract Study question Are symptomatic improvements in women with UF observed after 24 weeks of linzagolix treatment with or without add-back therapy (ABT) maintained over 52 weeks? Summary answer Improvements in anemia, pain and quality of life previously reported at 24 weeks were maintained at 52 weeks. What is known already We previously reported that partial or full suppression of estradiol (E2) with once daily doses of either 100 or 200 mg linzagolix for 24 weeks, with or without ABT, were effective in reducing heavy menstrual bleeding associated with uterine fibroids, improving other symptoms such as pain and anemia and improving quality of life. Here we report the maintenance of effect on secondary endpoints after 52 weeks of treatment. Study design, size, duration Linzagolix is an investigational, oral GnRH antagonist being developed to treat HMB due to UF. PRIMROSE 1 (P1, USA, NCT03070899) and PRIMROSE 2 (P2, Europe and USA, NCT03070951) are randomized, double-blind, placebo-controlled Phase 3 trials, with essentially identical design, investigating the efficacy and safety of linzagolix with and without hormonal add-back therapy (ABT: 1 mg estradiol/0.5 mg norethindrone acetate) once daily for 52 weeks. Participants/materials, setting, methods Participants had HMB due to UF (>80mL menstrual blood loss (MBL)/cycle) and were equally randomized to: placebo, linzagolix 100mg, linzagolix 100mg+ABT, linzagolix 200mg, or linzagolix 200mg+ABT. After 24 weeks, subjects originally randomized to placebo or linzagolix 200mg were switched to linzagolix 200mg+ABT except in P1 where 50% placebo subjects continued placebo until 52 weeks. Secondary efficacy assessments included hemoglobin, pain (0–10 numeric rating scale) and health related quality of life (HRQL) on the UF-QoL questionnaire. Main results and the role of chance P1 trial subjects (n = 526) had a mean age of 42 years, pain score of 6.6 and HRQL total score (0–100) of 36.4 and 63% were Black. P2 trial subjects (n = 511) had a mean age of 43 years, pain score 4.8 and HRQL total score of 46.1 and 5% were Black. Mean baseline MBL was about 200 mL per cycle in both studies. In both trials, significant improvements compared to placebo observed at week 24 for secondary endpoints, including pain, anemia and QoL in all linzagolix treatment groups were maintained at 52 weeks. Mean±SD hemoglobin levels in anemic patients (<12 g/dL) increased from baseline by 1.7±1.9, 1.9±1.7, 2.2±2.4, 2.7±1.9 in P1 and 1.2±1.9, 2.9±1.8, 2.4±2.1, 3.0±1.4 in P2 in the 100mg, 100mg+ABT, 200mg/200mg+ABT, 200mg+ABT groups, respectively, compared to 0.6±1.8 with placebo (P1). Mean±SD change from baseline in pain scores were -3.3±3.1, -2.7±3.2, -2.6±3.0, -3.9±3.2 in P1 and -2.6±3.1, -2.6±2.8, -3.0±2.6, -2.8±3.0 in P2 in the 100mg, 100mg+ABT, 200mg/200mg+ABT, 200mg+ABT groups, respectively, compared to -0.4±2.5 with placebo (P1). Mean±SD change in HRQL total scores were 25.0±26.2, 34.2±30.1, 29.7±29.2, 38.3±29.2 in P1 and 16.8±24.0, 29.6±23.2, 31.9±26.8, 30.7±26.0 in P2 in the 100mg, 100mg+ABT, 200mg/200mg+ABT, 200mg+ABT groups, respectively, compared to 14.6±23.9 with placebo (P1). Limitations, reasons for caution Here we report data in both trials up to 52 weeks of treatment. No statistical comparisons were done at 52 weeks (the primary analysis was done after 24 weeks treatment). Post-treatment follow-up will provide more information in symptom recurrence after stopping treatment. Wider implications of the findings All linzagolix treatments provided sustained benefit. Two regimens previously identified for potential long-term treatment, 200mg with ABT and 100mg without ABT, provided sustained improvements of anemia, pain and associated quality of life. These different treatment regimens could be important to address the diverse needs of women suffering from uterine fibroids. Trial registration number ClinicalTrials.gov: NCT03070899, NCT03070951

Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis

2020 ◽  
Vol 26 (2) ◽  
pp. 302-311
Author(s):  
Catherine Bergeron ◽  
Philippe Y Laberge ◽  
Amélie Boutin ◽  
Marie-Anne Thériault ◽  
Florence Valcourt ◽  
...  
Keyword(s):  
Side Effects ◽  
Statistical Significance ◽  
Treatment Options ◽  
Random Effect ◽  
Uterine Cavity ◽  
Premenopausal Women ◽  
Endometrial Ablation ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding

Abstract BACKGROUND Endometrial ablation/resection and the levonorgestrel intra-uterine system (LNG-IUS) are well-established treatment options for heavy menstrual bleeding to avoid more invasive alternatives, such as hysterectomy. OBJECTIVE The aim was to compare the efficacy and safety of endometrial ablation or resection with the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and to investigate sources of heterogeneity between studies. SEARCH METHODS We searched the databases MEDLINE, EMBASE, CENTRAL, Web of Science, Biosis and Google Scholar as well as citations and reference lists published up to August 2019. Two authors independently screened 3701 citations for eligibility. We included randomized controlled trials published in any language, comparing endometrial ablation or resection to the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and a normal uterine cavity. OUTCOMES Thirteen studies (N = 884) were eligible. Two independent authors extracted data and assessed the quality of included studies. Random effect models were used to compare the modalities and evaluate sources of heterogeneity. No significant differences were observed between endometrial ablation/resection and the LNG-IUS in terms of subsequent hysterectomy (primary outcome, risk ratio (RR) = 1.13, 95% CI 0.60 to 2.11, P = 0.71, I2 = 14%, 12 studies, 726 women), satisfaction, quality of life, amenorrhea and treatment failure. However, side effects were less common in women treated with endometrial ablation/resection compared to the LNG-IUS (RR = 0.52, 95% CI 0.37 to 0.71, P < 0.001, I2 = 0%, 10 studies, 580 women). Three complications were reported in the endometrial ablation/resection group and none in the LNG-IUS group (P = 0.25). Mean age of the studied populations was identified as a significant source of heterogeneity between studies in subgroup analysis (P = 0.01). In fact, endometrial ablation/resection was associated with a higher risk of subsequent hysterectomy compared to the LNG-IUS in younger populations (mean age ≤ 42 years old, RR = 5.26, 95% CI 1.21 to 22.91, P = 0.03, I2 = 0%, 3 studies, 189 women). On the contrary, subsequent hysterectomy seemed to be less likely with endometrial ablation/resection compared to the LNG-IUS in older populations (mean age > 42 years old), although the reduction did not reach statistical significance (RR = 0.51, 95% CI 0.21 to 1.24, P = 0.14, I2 = 0%, 5 studies, 297 women). Finally, sensitivity analysis taking into account the risk of bias of included studies and type of surgical devices (first and second generation) did not modify the results. Most of the included studies reported outcomes at up to 3 years, and the relative performance of endometrial ablation/resection and LNG-IUS remains unknown in the longer term. WIDER IMPLICATIONS Endometrial ablation/resection and the LNG-IUS are two excellent treatment options for heavy menstrual bleeding, although women treated with the LNG-IUS are at higher risk of experiencing side effects compared to endometrial ablation/resection. Otherwise, younger women seem to present a lower risk of eventually requiring hysterectomy when treated with the LNG-IUS compared to endometrial ablation/resection.

Heavy menstrual bleeding significantly affects quality of life

2013 ◽  
Vol 93 (1) ◽  
pp. 52-57 ◽  
Author(s):  
Trine S. Karlsson ◽  
Lena B. Marions ◽  
Måns G. Edlund
Keyword(s):  
Quality Of Life ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding

scholarly journals The prevalence and impacts heavy menstrual bleeding on anemia, fatigue and quality of life in women of reproductive age

2019 ◽  
Vol 35 (2) ◽  
Author(s):  
Semra Kocaoz ◽  
Rabiye Cirpan ◽  
Arife Zuhal Degirmencioglu
Keyword(s):  
Quality Of Life ◽  
Ferritin Level ◽  
Reproductive Age ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding ◽  
Women Of Reproductive Age ◽  
Creative Commons ◽  
Sf 36 ◽  
Quality Of Life Scale

Objectives: To investigate the prevalence and impacts of heavy menstrual bleeding (HMB) on anemia, fatigue, and the quality of life (QoL) in women of reproductive age. Methods: This study was conducted among 306 women of reproductive age who presented at the internal medicine outpatient departments of the training and research hospital of a university. The data of the study were collected by the “Data collection form”, “SF-36 Quality of Life Scale (SF-36 QoLS)” and “Brief Fatigue Inventory (BFI)”. Results: The prevalence of HMB in women of reproductive age was 37.9%. The ferritin level and physical functions were found to decrease significantly as the duration of menstruation increased (p<0.05). Besides, a positive but very weak relationship was found between the menstruation duration and the subdimensions of the global BFI and the general health perception subscale of the SF-36 QoLS (p<0.05). Conclusion: It was determined that HMB is common and has negative effects on anemia, fatigue and some subdimensions of the QoL. Regular screening for HMB that may not be expressed by many women may therefore be useful in preventing and resolving the health problems that it will cause. How to cite this:Kocaoz S, Cirpan R, Degirmencioglu AZ. The prevalence and impacts heavy menstrual bleeding on anemia, fatigue and quality of life in women of reproductive age. Pak J Med Sci. 2019;35(2):---------. doi: https://doi.org/10.12669/pjms.35.2.644 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Juliawati Muhammad ◽  
Yusnita Yusof ◽  
Imran Ahmad ◽  
Mohd Noor Norhayati
Keyword(s):  
Uterine Fibroid ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Premenopausal Women ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding ◽  
Moderate Quality ◽  
Quality Evidence ◽  
Norethindrone Acetate

Abstract Background Elagolix is effective and safe for treating menorrhagia in women with uterine fibroid. However, it is reported to be associated with hypoestrogenism that can be alleviated by adding estradiol/norethindrone acetate. This systematic review and meta-analysis aimed to determine the effectiveness of elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid by comparing: elagolix versus placebo and elagolix versus estradiol/norethindrone acetate. Methodology The Cochrane Central Register of Controlled Trials (CENTRAL 2021, Issue 3 of 12), MEDLINE databases (1980 to December week 1, 2020), and trial registries for relevant randomized clinical trials were used. All randomized clinical trials were reviewed and evaluated. Random effects models were used to estimate the dichotomous outcomes and mean differences with 95% confidence intervals. Data for risk of bias, heterogeneity, sensitivity, reporting bias and quality of evidence were assessed. Results Four randomized controlled trials with 1949 premenopausal women from 323 locations were included. Elagolix improved menstrual blood loss of less than 80 ml (RR 4.81, 95% CI 2.45 to 9.45; four trials, 869 participants; moderate quality evidence) or more than 50% reduction from baseline (RR 4.87, 95% CI 2.55 to 9.31; four trials, 869 participants; moderate quality evidence) compared to placebo. There was no difference in menstrual blood loss of less than 80 ml (RR 1.08, 95% CI 1.00 to 1.16; five trials, 1365 participants; moderate quality evidence) or more than 50% reduction from baseline between the elagolix (RR 1.08, 95% CI 1.01 to 1.15; five trials, 1365 participants; high quality evidence) and elagolix with estradiol/norethindrone acetate. In both comparisons, elagolix has reduced the mean percentage change in uterine and fibroid volume, improved symptoms, and health-related quality of life. More patients had hot flush, and bone mineral density loss in the elagolix treatment compared to both placebo and elagolix with estradiol/norethindrone acetate. Conclusions Elagolix appeared to be effective in reducing heavy menstrual bleeding caused by uterine fibroid and combination with estradiol/norethindrone acetate was able to alleviate the hypoestrogenism side effects in premenopausal women. Review registration PROSPERO CDR 42021233898.

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