Summary:
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix (Dose 1 and Dose 2) versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Approximately 875 subjects will be enrolled into the study at approximately 160 sites.
The study consists of 4 periods:
1) Washout Period (if applicable)
2) a Screening Period of up to 75 days prior to first dose
3) a 6 month Treatment Period
4) a Post treatment Follow-up Period of up to 12 months (if applicable).
An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use non-hormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
Qualified Participants Must:
• Be a premenopausal female, between 18 and 49 years of age
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Have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 7 years
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Use required birth control methods during the entire length of participation in the study
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Have at least two regular menstrual cycles (28 days ± 5 days)