A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
NCT ID: NCT01116440
Last Updated: 2020-11-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
27 participants
INTERVENTIONAL
2010-04-15
2012-03-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BGS649 co-administered with Levora 28™
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.
Placebo co-administered with Levora 28™
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Mereo BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Jacqueline Parkin, PhD FRCP
Role: STUDY_DIRECTOR
Mereo BioPharma
Locations
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University of South Alabama Medical Center
Mobile, Alabama, United States
Precision Trials
Phoenix, Arizona, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Center for Fertility and Women's Health
New Britain, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Zasa Clinical Research
Boynton Beach, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
University of Miami School of Medicine & Clinics
Miami, Florida, United States
West Broward OB/GYN Associates
Plantation, Florida, United States
Comprehensive Clinical Trials,LLC
West Palm Beach, Florida, United States
Associated Pharmaceutical Research
Decatur, Georgia, United States
Legacy Obstetrics & Gynecology
Decatur, Georgia, United States
Minority Clinical Research Center of Atlanta
Riverdale, Georgia, United States
Christie Clinic
Champaign, Illinois, United States
Women's Health Practice Center
Champaign, Illinois, United States
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, United States
Green Clinic, LLC
Ruston, Louisiana, United States
NECCR
Fall River, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Montana Medical Research
Missoula, Montana, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Women's Health Research Center
Plainsboro, New Jersey, United States
Southwest Clinical Research
Albuquerque, New Mexico, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
HWC Women's Research Center
Englewood, Ohio, United States
Promedica Health System
Toledo, Ohio, United States
Ilumina Clinical Associates
Hopwood, Pennsylvania, United States
Medical Research South
Charleston, South Carolina, United States
Greenville Hospital System
Greenville, South Carolina, United States
Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina, United States
Practice Research Organization
Dallas, Texas, United States
Centex Research
Houston, Texas, United States
Bexar Clinical Trials
Irving, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Eastern Va Medical School
Norfolk, Virginia, United States
VCU Health Systems, MCV
Richmond, Virginia, United States
Valley Women's Clinic
Renton, Washington, United States
Henry Rodriguez-Ginorio, MD
San Juan, Pr, Puerto Rico
Ponce School of Medicine
Ponce, , Puerto Rico
Countries
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Other Identifiers
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CBGS649A2202
Identifier Type: -
Identifier Source: org_study_id