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

Mereo BioPharma44 sites in 2 countries27 target enrollmentApril 15, 2010

ConditionsPelvic Pain Associated With Refractory Endometriosis

InterventionsBGS649 Placebo

DrugsBGS649 Placebo

Overview

Phase: Phase 2
Intervention: BGS649
Conditions: Pelvic Pain Associated With Refractory Endometriosis
Sponsor: Mereo BioPharma
Enrollment: 27
Locations: 44
Primary Endpoint: Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

April 15, 2010

End Date

March 21, 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Mereo BioPharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have surgical diagnosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase
•Subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy

Exclusion Criteria

•Subjects who have undergone hysterectomy or bilateral oophorectomy.
•Surgical treatment of endometriosis within 3 months before screening.
•Subjects who are pregnant or who were pregnant within 3 months of visit one.
•Subjects who are nursing or lactating
•Subjects who are tobacco smokers.
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

BGS649 co-administered with Levora 28™

Intervention: BGS649

Placebo co-administered with Levora 28™

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score

Time Frame: 12 weeks

Mean change from baseline to Month 3 (Week 12) in Number Rating Scale pelvic pain score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine.

Secondary Outcomes

Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores(4 weeks)
Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score(12 weeks)
Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores(8 weeks)
Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale(12 weeks)