Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix

Sanjay K Agarwal; Sukhbir S Singh; David F Archer; Yabing Mai; Kristof Chwalisz; Keith Gordon; Eric Surrey

doi:10.2147/JPR.S284703

Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix

J Pain Res. 2021 Feb 2:14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021.

Authors

Sanjay K Agarwal¹, Sukhbir S Singh², David F Archer³, Yabing Mai⁴, Kristof Chwalisz⁵, Keith Gordon⁶, Eric Surrey⁷

Affiliations

¹ Department of Obstetrics and Gynecology and Reproductive Sciences, Center for Endometriosis Research and Treatment, UC San Diego, La Jolla, CA, USA.
² Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
³ Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA.
⁴ Statistics, AbbVie Inc, North Chicago, IL, USA.
⁵ Clinical Development, AbbVie Inc, North Chicago, IL, USA.
⁶ Medical Affairs, AbbVie Inc, North Chicago, IL, USA.
⁷ Colorado Center for Reproductive Medicine, Lone Tree, CO, USA.

Abstract

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.

Associated data

ClinicalTrials.gov/NCT01931670
ClinicalTrials.gov/NCT01620528

Grants and funding

AbbVie Inc. funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the manuscript for publication.