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
1 other identifier
interventional
27
2 countries
44
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2010
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2010
CompletedFirst Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2012
CompletedResults Posted
Study results publicly available
October 30, 2020
CompletedNovember 23, 2020
November 1, 2020
1.2 years
May 3, 2010
October 26, 2017
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
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.
12 weeks
Secondary Outcomes (4)
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
Study Arms (2)
BGS649 co-administered with Levora 28™
EXPERIMENTALPlacebo co-administered with Levora 28™
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mereo BioPharmalead
- Novartiscollaborator
Study Sites (44)
University of South Alabama Medical Center
Mobile, Alabama, 36617, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Center for Fertility and Women's Health
New Britain, Connecticut, 06052, United States
Yale New Haven Hospital
New Haven, Connecticut, 06504, United States
Zasa Clinical Research
Boynton Beach, Florida, 33437, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
University of Miami School of Medicine & Clinics
Miami, Florida, 33136, United States
West Broward OB/GYN Associates
Plantation, Florida, 33324, United States
Comprehensive Clinical Trials,LLC
West Palm Beach, Florida, 33409, United States
Associated Pharmaceutical Research
Decatur, Georgia, 30034, United States
Legacy Obstetrics & Gynecology
Decatur, Georgia, 30035, United States
Minority Clinical Research Center of Atlanta
Riverdale, Georgia, 30274, United States
Christie Clinic
Champaign, Illinois, 61820, United States
Women's Health Practice Center
Champaign, Illinois, 61820, United States
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226, United States
Green Clinic, LLC
Ruston, Louisiana, 71270, United States
NECCR
Fall River, Massachusetts, 02720, United States
Wayne State University
Detroit, Michigan, 48034, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Women's Health Research Center
Plainsboro, New Jersey, 08536, United States
Southwest Clinical Research
Albuquerque, New Mexico, 87102, United States
New Hanover Medical Research
Wilmington, North Carolina, 28401, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
Promedica Health System
Toledo, Ohio, 43606, United States
Ilumina Clinical Associates
Hopwood, Pennsylvania, 15445, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Greenville Hospital System
Greenville, South Carolina, 26905, United States
Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina, 29572, United States
Practice Research Organization
Dallas, Texas, 75230, United States
Centex Research
Houston, Texas, 77079, United States
Bexar Clinical Trials
Irving, Texas, 75061, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Eastern Va Medical School
Norfolk, Virginia, 23507, United States
VCU Health Systems, MCV
Richmond, Virginia, 23230, United States
Valley Women's Clinic
Renton, Washington, 98055, United States
Henry Rodriguez-Ginorio, MD
San Juan, Pr, 00917, Puerto Rico
Ponce School of Medicine
Ponce, 00716, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
After unblinding it was found that one of the placebo patients had been given active drug. Therefore the safety populations has 12 patients on active and 15 on placebo. The study was terminated for administrative reasons.
Results Point of Contact
- Title
- William Moore
- Organization
- Mereo BioPharma Group Plc.
Study Officials
- STUDY DIRECTOR
Jacqueline Parkin, PhD FRCP
Mereo BioPharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 5, 2010
Study Start
April 15, 2010
Primary Completion
July 1, 2011
Study Completion
March 21, 2012
Last Updated
November 23, 2020
Results First Posted
October 30, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share