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



Status:Terminated
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 49
Updated:12/1/2017
Start Date:April 2010

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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

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


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
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque, New Mexico 87102
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Boynton Beach, Florida 33437
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Champaign, Illinois 61820
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Champaign, Illinois 61820
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Charleston, South Carolina 29407
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Clearwater, Florida 33759
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Dallas, TX
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Decatur, Georgia 30034
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4166 Snapfinger Woods Drive
Decatur, Georgia 30035
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1565 North Main Street
Fall River, Massachusetts 02720
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Greenville, South Carolina 29615
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Hato Rey, 00917
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136 Jaycee Drive
Hopwood, Pennsylvania 15445
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Houston, Texas 77079
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Irving, Texas 75061
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Jonesboro, Arkansas 72401
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Myrtle Beach, South Carolina 29572
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Naperville, Illinois 60540
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Renton, Washington 98055
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57 North 11th Street
Richmond, Virginia 23230
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