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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvic Pain Associated With Refractory Endometriosis

Intervention: BGS649 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To demonstrate that from baseline of mean pelvic pain score during month 3 is significantly greater on BGS649 treatment(plus COC)combined oral contraceptive as compared to placebo(plus COC)in patients with refractory endometriosis.

Secondary outcome:

The change from baseline in mean pelvic pain score

The proportion of patients achieving a response in the pelvic pain score (greater than or equal to 1-point improvement from baseline on the modified B&B scale)

The change from baseline in the pain associated with sexual intercourse (NRS) and the number of days the patient had sexual intercourse

The percent change from baseline in mean pelvic pain (NRS) score defined as >=2-point improvement in the NRS & >=30% improvement in the NRS

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Female.

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

Locations and Contacts

Henry Rodriguez-Ginorio, MD, Hato Rey 00917, Puerto Rico

Ponce School of Medicine, Ponce 00716, Puerto Rico

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

Cypress Medical Research Center, LLC, Wichita, Kansas 67226, United States

Heartland Research Associates, LLC, Wichita, Kansas 67207, 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

Additional Information

click here for recruitment information

click here for recruitment information

Starting date: April 2010
Last updated: July 20, 2011

Page last updated: August 23, 2015

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