NCT01116440

A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis

A Double Blind, Randomized, Controlled, Multicenter, Efficacy and Safety Study of Oral BGS649 vs. Placebo (Each Co-administered With a Combined Oral Contraceptive) Assessing Pain Response in Patients With Refractory Endometriosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis

Conditions

• Pelvic Pain Associated With Refractory Endometriosis

Interventions

Type	Name	Description
DRUG	BGS649	0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.
DRUG	Placebo	Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.

Timeline

• Start date: 2010-04-15
• Primary completion: 2011-07-01
• Completion: 2012-03-21
• First posted: 2010-05-05
• Last updated: 2020-11-23
• Results posted: 2020-10-30

Locations

44 sites across 2 countries: United States, Puerto Rico