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

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

Study Overview

• Status: Terminated
• Conditions: Pelvic Pain Associated With Refractory Endometriosis
• Intervention / Treatment: Drug: BGS649; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine
  • San Juan, Puerto Rico, 00917
    • Henry Rodriguez-Ginorio, MD
• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • University of South Alabama Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Northeast Arkansas Clinic
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • Center for Fertility and Women's Health
    • New Haven, Connecticut, United States, 06504
      • Yale New Haven Hospital
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Zasa Clinical Research
    • Clearwater, Florida, United States, 33759
      • Women's Medical Research Group, LLC
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine & Clinics
    • Plantation, Florida, United States, 33324
      • West Broward OB/GYN Associates
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials,LLC
  • Georgia
    • Decatur, Georgia, United States, 30034
      • Associated Pharmaceutical Research
    • Decatur, Georgia, United States, 30035
      • Legacy Obstetrics & Gynecology
    • Riverdale, Georgia, United States, 30274
      • Minority Clinical Research Center of Atlanta
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Christie Clinic
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice Center
    • Naperville, Illinois, United States, 60540
      • The Advanced Gynecologic Surgery Institute
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center, LLC
  • Louisiana
    • Ruston, Louisiana, United States, 71270
      • Green Clinic, LLC
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • NECCR
  • Michigan
    • Detroit, Michigan, United States, 48034
      • Wayne State University
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Plainsboro, New Jersey, United States, 08536
      • Women's Health Research Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Southwest Clinical Research
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Medical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Gynecologic Associates
  • Ohio
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
    • Toledo, Ohio, United States, 43606
      • ProMedica Health System
  • Pennsylvania
    • Hopwood, Pennsylvania, United States, 15445
      • Ilumina Clinical Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South
    • Greenville, South Carolina, United States, 26905
      • Greenville Hospital System
    • Myrtle Beach, South Carolina, United States, 29572
      • Magnolia Ob/Gyn Research Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Practice Research Organization
    • Houston, Texas, United States, 77079
      • Centex Research
    • Irving, Texas, United States, 75061
      • Bexar Clinical Trials
    • Lake Jackson, Texas, United States, 77566
      • R/D Clinical Research, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern VA Medical School
    • Richmond, Virginia, United States, 23230
      • VCU Health Systems, MCV
  • Washington
    • Renton, Washington, United States, 98055
      • Valley Women's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGS649 co-administered with Levora 28™	Drug: 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 Comparator: Placebo co-administered with Levora 28™	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores	Mean change from baseline in Numeric Rating Scale pelvic pain scores to 4 weeks. 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.	4 weeks
Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score	The proportion (expressed as a percentage) of patients achieving a response in the Numeric Rating Scale pelvic pain score where a response is defined as greater than or equal to 2-point improvement from baseline or a greater than or equal to 30% improvement in the 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
Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores	Mean change from baseline in Numeric Rating Scale pelvic pain scores to 8 weeks. Where the Numeric Rate Scale Pelvic Pain Score is a scale between 0 and 10, where 0 is no pain and is the worse pain you can imagine.	8 weeks
Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale	The proportion of patients (expressed as a percentage) achieving a response to their pelvic pain score measure on the Biberoglu and Behrman pelvic pain score where a response is defined as a greater than or equal to 1-point improvement from baseline. B & B scales allow for grading pain with a score between 0 and 4 with higher number being more severe pain.	12 weeks

Collaborators and Investigators

• Sponsor: Mereo BioPharma
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): March 21, 2012

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pelvic pain; Menstrual pain; Refractory endometriosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: CBGS649A2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No