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

Phase 2

Terminated

Conditions: Pelvic Pain Associated With Refractory Endometriosis

Interventions: Drug: BGS649
Drug: Placebo

Registration Number: NCT01116440

Lead Sponsor: Mereo BioPharma

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 27

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BGS649 co-administered with Levora 28™	BGS649	-
Placebo co-administered with Levora 28™	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score	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 Outcome Measures

Name	Time	Method
Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores	4 weeks	Mean change from baseline in Numeric Rating Scale pelvic pain scores to 4 weeks. 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.
Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score	12 weeks	The proportion (expressed as a percentage) of patients achieving a response in the Numeric Rating Scale pelvic pain score where a response is defined as greater than or equal to 2-point improvement from baseline or a greater than or equal to 30% improvement in the 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.
Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores	8 weeks	Mean change from baseline in Numeric Rating Scale pelvic pain scores to 8 weeks. Where the Numeric Rate Scale Pelvic Pain Score is a scale between 0 and 10, where 0 is no pain and is the worse pain you can imagine.
Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale	12 weeks	The proportion of patients (expressed as a percentage) achieving a response to their pelvic pain score measure on the Biberoglu and Behrman pelvic pain score where a response is defined as a greater than or equal to 1-point improvement from baseline. B \& B scales allow for grading pain with a score between 0 and 4 with higher number being more severe pain.

Trial Locations

Locations (44): University of South Alabama Medical Center
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Mobile, Alabama, United States
Center for Fertility and Women's Health
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New Britain, Connecticut, United States
Practice Research Organization
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Dallas, Texas, United States
West Broward OB/GYN Associates
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Plantation, Florida, United States
Comprehensive Clinical Trials,LLC
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West Palm Beach, Florida, United States
Centex Research
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Houston, Texas, United States
Women's Health Research Center
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Plainsboro, New Jersey, United States
Henry Rodriguez-Ginorio, MD
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San Juan, Puerto Rico
Greenville Hospital System
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Greenville, South Carolina, United States
Magnolia OB/GYN Research Center
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Myrtle Beach, South Carolina, United States
Northeast Arkansas Clinic
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Jonesboro, Arkansas, United States
Yale New Haven Hospital
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New Haven, Connecticut, United States
Medical Research South
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Charleston, South Carolina, United States
Wayne State University
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Detroit, Michigan, United States
Precision Trials
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Phoenix, Arizona, United States
Legacy Obstetrics & Gynecology
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Decatur, Georgia, United States
The Advanced Gynecologic Surgery Institute
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Naperville, Illinois, United States
Lyndhurst Gynecologic Associates
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Winston-Salem, North Carolina, United States
NECCR
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Fall River, Massachusetts, United States
Montana Medical Research
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Missoula, Montana, United States
Women's Health Practice Center
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Champaign, Illinois, United States
Heartland Research Associates, LLC
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Wichita, Kansas, United States
Cooper University Hospital
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Camden, New Jersey, United States
HWC Women's Research Center
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Englewood, Ohio, United States
Minority Clinical Research Center of Atlanta
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Riverdale, Georgia, United States
Cypress Medical Research Center, LLC
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Wichita, Kansas, United States
Women's Medical Research Group, LLC
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Clearwater, Florida, United States
Women's Clinic of Lincoln, PC
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Lincoln, Nebraska, United States
Eastern Va Medical School
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Norfolk, Virginia, United States
VCU Health Systems, MCV
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Richmond, Virginia, United States
Valley Women's Clinic
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Renton, Washington, United States
Associated Pharmaceutical Research
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Decatur, Georgia, United States
University of Miami School of Medicine & Clinics
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Miami, Florida, United States
Green Clinic, LLC
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Ruston, Louisiana, United States
Ponce School of Medicine
🇵🇷
Ponce, Puerto Rico
Christie Clinic
🇺🇸
Champaign, Illinois, United States
Zasa Clinical Research
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Boynton Beach, Florida, United States
Saginaw Valley Medical Research Group, LLC
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Saginaw, Michigan, United States
Ilumina Clinical Associates
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Hopwood, Pennsylvania, United States
Promedica Health System
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Toledo, Ohio, United States
Southwest Clinical Research
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Albuquerque, New Mexico, United States
R/D Clinical Research, Inc.
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Lake Jackson, Texas, United States
New Hanover Medical Research
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Wilmington, North Carolina, United States
Bexar Clinical Trials
🇺🇸
Irving, Texas, United States