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https://observatorio.fm.usp.br/handle/OPI/34465
Title: | Elagolix reduced dyspareunia and improved health-related quality of life in premenopausal women with endometriosis-associated pain |
Authors: | LEYLAND, Nicholas; TAYLOR, Hugh S.; ARCHER, David F.; PELOSO, Paul M.; SOLIMAN, Ahmed M.; PALAC, Hannah L.; MARTINEZ, Marisol; ABRAO, Mauricio S. |
Citation: | JOURNAL OF ENDOMETRIOSIS AND PELVIC PAIN DISORDERS, v.11, n.4, p.171-180, 2019 |
Abstract: | Objectives: The objective was to evaluate the effects of elagolix on dyspareunia in women with endometriosis-associated pain. Methods: Data were pooled from two similar, randomized, double-blind, placebo-controlled, 6-month phase 3 studies (Elaris Endometriosis-I and Elaris Endometriosis-II) of elagolix at two doses (150 mg QD and 200 mg BID) in women with endometriosis-associated pain. In this post hoc analysis, dyspareunia responders were defined as having a clinically meaningful decrease from baseline in the dyspareunia score and decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. Sexual relationship was assessed using the 30-item Endometriosis Health Profile questionnaire sexual relationship module. Results: A total of 1384 women reported > 1 day of sexual activity at baseline (35 days prior to and including day 1 of treatment). Of these 1384 women, 1297 (94%) reported > 1 day of any dyspareunia (mild, moderate, or severe), of which 51% reported > 1 day of severe dyspareunia. Among sexually active women who reported any dyspareunia at baseline, both elagolix doses led to improvements in dyspareunia. Women in the 200-mg BID group showed more months at which the dyspareunia response rates were statistically significantly greater than placebo, particularly in a subgroup of women with severe dyspareunia at baseline. Compared to placebo, both elagolix doses led to statistically significantly greater improvements in the mean 30-item Endometriosis Health Profile sexual relationship module score. Conclusion: Up to 6 months of elagolix treatment improved dyspareunia in women with endometriosis-associated pain in a dose-dependent manner, with 200-mg BID dose showing the most significant improvements in dyspareunia and quality of sexual relationships compared with placebo. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/MOG Artigos e Materiais de Revistas Científicas - LIM/58 |
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