Treatment of uterine fibroid symptoms with relugolix combination therapy

Uterine fibroids are a common cause of heavy menstrual bleeding and pain. Treatment with the combination of relugolix (an oral gonadotropin-releasing hormonereceptor antagonist), estradiol, and norethindrone acetate, administered once daily, may have efficacy in women with uterine fibroids and heavy...

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Published in:Reproductive health of woman (Online) 2024-05 (4), p.53-62
Main Authors: Al-Hendy, Ayman, Lukes, Andrea S., Poindexter, Alfred N., Venturella, Roberta, Villarroel, Claudio, Critchley, Hilary O.D., Li, Yulan, McKain, Laura, Ferreira, Juan C. Arjona, Langenberg, Andria G.M., Wagman, Rachel B., Stewart, Elizabeth A.
Format: Article
Language:English
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Summary:Uterine fibroids are a common cause of heavy menstrual bleeding and pain. Treatment with the combination of relugolix (an oral gonadotropin-releasing hormonereceptor antagonist), estradiol, and norethindrone acetate, administered once daily, may have efficacy in women with uterine fibroids and heavy bleeding while avoiding hypoestrogenic effects. Methods. We conducted two replicate international, double-blind, 24-week, phase 3 trials involving women with fibroid-associated heavy menstrual bleeding. Participants were randomly assigned in a 1:1:1 ratio to receive once-daily placebo, relugolix combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate), or delayed relugolix combination therapy (40 mg of relugolix monotherapy, followed by relugolix combination therapy, each for 12 weeks). The primary efficacy end point in each trial was the percentage of participants with a response (volume of menstrual blood loss
ISSN:2708-8723
2708-8731
DOI:10.30841/2708-8731.4.2024.308996