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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

• Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3 [ Time Frame: Baseline and end of menses Cycle 3 (approximately 12 weeks) ]
  MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
• Number of subjects with adverse events (AE) [ Time Frame: Up to 3 months ]
  An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3 [ Time Frame: Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks) ]
  MBL will be measured from blood collected from menstrual cycle by-products
• Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle [ Time Frame: Up to 3 months ]
  Average daily dysmenorrhea score from Day -1 to Day 2 of menses

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: June 6, 2016
Date Started: July 2016
Date Completion: October 2016
Last Updated: January 16, 2017
Last Verified: January 2017