Vaginal Bromocriptine Improves Pain, Menstrual Bleeding, and Quality of Life in Women With Adenomyosis

2020 ◽  
Vol 75 (1) ◽  
pp. 27-28
Author(s):  
Johanna K. Andersson ◽  
Zaraq Khan ◽  
Amy L. Weaver ◽  
Lisa E. Vaughan ◽  
Kristina Gemzell-Danielsson ◽  
...  
2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
H Taylor ◽  
J Donnez ◽  
F Petraglia ◽  
K Gemzell Danielsson ◽  
S Renner ◽  
...  

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


2019 ◽  
Vol 98 (10) ◽  
pp. 1341-1350 ◽  
Author(s):  
Johanna K. Andersson ◽  
Zaraq Khan ◽  
Amy L. Weaver ◽  
Lisa E. Vaughan ◽  
Kristina Gemzell‐Danielsson ◽  
...  

2013 ◽  
Vol 93 (1) ◽  
pp. 52-57 ◽  
Author(s):  
Trine S. Karlsson ◽  
Lena B. Marions ◽  
Måns G. Edlund

2019 ◽  
Vol 35 (2) ◽  
Author(s):  
Semra Kocaoz ◽  
Rabiye Cirpan ◽  
Arife Zuhal Degirmencioglu

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.


2015 ◽  
Vol 7 (1) ◽  
pp. 5-9
Author(s):  
Harpreet Kaur ◽  
Sushmita Sharma ◽  
SPS Goraya

ABSTRACT Abnormal menstrual bleeding (AMB) is a common gynecological complaint. It may have serious repercussions on women's quality of life. Most of the studies on abnormal menstrual bleeding focus on the quantity of blood loss with little emphasis on the effect, it has on the quality of women's life. Recent research in the area of abnormal menstrual bleeding has recognized the importance of the ‘patient experience’ as an outcome that should be measured. So, it is very important to know about women's perception about the problem so that the healthcare professional can provide them appropriate care. The present study was undertaken to assess effect of AMB on various aspects of women's life and to assess their knowledge toward causes and management of AMB and its health impacts. Though majority of women know about abnormal bleeding as something serious, but still they lack in depth understanding of its consequences and various treatment modalities available. Significance for public research The article gives us valuable inputs regarding patient's viewpoint about abnormal uterine bleeding. Knowing the patients perceptions, their attitude toward abnormal menstrual bleeding and various social factors affecting it may be very helpful for the health professionals and researchers in knowing the impact of abnormal bleeding on quality of life and hence selecting the treatment strategies that will improve patient's satisfaction. How to cite this article Kaur H, Sharma S, Goraya SPS. Knowledge, Attitude and Behavior of Women toward Abnormal Menstrual Bleeding and Its Impact on Quality of Life. J South Asian Feder Obst Gynae 2015;7(1):5-9.


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