Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
Status:
Withdrawn
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to assess the efficacy, safety, and tolerability of
epelsiban compared with placebo in treatment of women with adenomyosis.
This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an
interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of
epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be
composed of three periods: screening, treatment, and follow-up and the total time a subject
will be in the study will be approximately 6 months.