Clinical trial NCT01116440: A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pelvic Pain Associated With Refractory Endometriosis
Keywords: Menstrual pain
Refractory endometriosis
Pelvic pain
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2010-05-05
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores
timeFrame: 4 weeks
measure: Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score
timeFrame: 12 weeks
measure: Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores
timeFrame: 8 weeks
measure: Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: New Britain
country: United States
facility: Center for Fertility and Women's Health
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Boynton Beach
country: United States
facility: Zasa Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine & Clinics
state: Florida
city: Plantation
country: United States
facility: West Broward OB/GYN Associates
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials,LLC
state: Florida
city: Decatur
country: United States
facility: Associated Pharmaceutical Research
state: Georgia
city: Decatur
country: United States
facility: Legacy Obstetrics & Gynecology
state: Georgia
city: Riverdale
country: United States
facility: Minority Clinical Research Center of Atlanta
state: Georgia
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Champaign
country: United States
facility: Women's Health Practice Center
state: Illinois
city: Naperville
country: United States
facility: The Advanced Gynecologic Surgery Institute
state: Illinois
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC
state: Kansas
city: Ruston
country: United States
facility: Green Clinic, LLC
state: Louisiana
city: Fall River
country: United States
facility: NECCR
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest Clinical Research
state: New Mexico
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Toledo
country: United States
facility: Promedica Health System
state: Ohio
city: Hopwood
country: United States
facility: Ilumina Clinical Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Myrtle Beach
country: United States
facility: Magnolia OB/GYN Research Center
state: South Carolina
city: Dallas
country: United States
facility: Practice Research Organization
state: Texas
city: Houston
country: United States
facility: Centex Research
state: Texas
city: Irving
country: United States
facility: Bexar Clinical Trials
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Norfolk
country: United States
facility: Eastern Va Medical School
state: Virginia
city: Richmond
country: United States
facility: VCU Health Systems, MCV
state: Virginia
city: Renton
country: United States
facility: Valley Women's Clinic
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine
city: San Juan
country: Puerto Rico
facility: Henry Rodriguez-Ginorio, MD
Study officials:
affiliation: Mereo BioPharma
name: Jacqueline Parkin, PhD FRCP
role: STUDY_DIRECTOR
References: