Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix
Received 30 September 2020
Accepted for publication 12 January 2021
Published 2 February 2021 Volume 2021:14 Pages 263—271
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr E Alfonso Romero-Sandoval
Sanjay K Agarwal,1 Sukhbir S Singh,2 David F Archer,3 Yabing Mai,4 Kristof Chwalisz,5 Keith Gordon,6 Eric Surrey7
1Department of Obstetrics and Gynecology and Reproductive Sciences, Center for Endometriosis Research and Treatment, UC San Diego, La Jolla, CA, USA; 2Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; 3Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA; 4 Statistics, AbbVie Inc, North Chicago, IL, USA; 5Clinical Development, AbbVie Inc, North Chicago, IL, USA; 6Medical Affairs, AbbVie Inc, North Chicago, IL, USA; 7Colorado Center for Reproductive Medicine, Lone Tree, CO, USA
Correspondence: Sanjay K Agarwal
Department of Obstetrics and Gynecology and Reproductive Sciences, Center for Endometriosis Research and Treatment, UC San Diego, 9500 Gilman Drive, #0633, La Jolla, CA, USA
Tel +1 (858) 534-8930
Objective: In this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) and nonmenstrual (nonbleeding) days.
Methods: Data from two randomized, 6-month, placebo-controlled trials (Elaris Endometriosis (EM)-I and EM-II) of elagolix (150 mg once daily (QD) and 200 mg twice daily (BID)) in premenopausal women with moderate to severe endometriosis-associated pain (N = 1686) were pooled. Women recorded the presence of menstrual period and severity of dysmenorrhea or nonmenstrual pelvic pain in a daily electronic diary.
Results: At baseline, women in the placebo group and both elagolix treatment groups reported moderate or severe dysmenorrhea, on average, 81% of their menstrual period days and moderate/severe nonmenstrual pelvic pain, on average, 56% of their nonmenstrual (nonbleeding) days. Compared with placebo at month 6, elagolix-treated women had a significantly lower mean (standard deviation (SD)) percentage of menstrual period days with moderate or severe dysmenorrhea (elagolix 150 mg QD = 52.4 (38.9), p = 0.002; elagolix 200 mg BID = 38.5 (43.6), p < 0.001, placebo = 61.3 (33.7)) and a significantly lower mean (SD) percentage of nonmenstrual (nonbleeding) days with moderate or severe nonmenstrual pelvic pain (elagolix 150 mg QD = 31.1 (35.8), p < 0.001; elagolix 200 mg BID = 19.7 (29.9), p < 0.001; placebo = 35.6 (33.9)).
Conclusion: Following 6 months of elagolix treatment, women who still menstruated had a lower proportion of menstrual period days with moderate or severe dysmenorrhea compared with placebo, demonstrating pain reduction despite continued menses. Additionally, pain did not shift from dysmenorrhea to nonmenstrual pelvic pain, as the percentage of days with moderate or severe nonmenstrual pelvic pain was also reduced for elagolix-treated women compared with placebo.
Trial Registration: The Elaris EM-I study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01620528. The Elaris EM-II study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01931670. Both studies are registered with the EU Clinical Trial Register, www.clinicaltrialsregister.ed, 2011-004295-11.
Keywords: bleeding, dysmenorrhea, elagolix, endometriosis, nonmenstrual pelvic pain
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