NCT02794467

Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenomyosis

Interventions

Type	Name	Description
DRUG	Epelsiban	Epelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing
DRUG	Placebo	A matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing.

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-06-09
• Last updated: 2017-01-18

Locations

13 sites across 1 country: United States