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

Primary Purpose

Pelvic Pain Associated With Refractory Endometriosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGS649
Placebo
Sponsored by
Mereo BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain Associated With Refractory Endometriosis focused on measuring Menstrual pain, Refractory endometriosis, Pelvic pain

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama Medical Center
  • Precision Trials
  • Northeast Arkansas Clinic
  • Center for Fertility and Women's Health
  • Yale New Haven Hospital
  • Zasa Clinical Research
  • Women's Medical Research Group, LLC
  • University of Miami School of Medicine & Clinics
  • West Broward OB/GYN Associates
  • Comprehensive Clinical Trials,LLC
  • Associated Pharmaceutical Research
  • Legacy Obstetrics & Gynecology
  • Minority Clinical Research Center of Atlanta
  • Christie Clinic
  • Women's Health Practice Center
  • The Advanced Gynecologic Surgery Institute
  • Heartland Research Associates, LLC
  • Cypress Medical Research Center, LLC
  • Green Clinic, LLC
  • NECCR
  • Wayne State University
  • Saginaw Valley Medical Research Group, LLC
  • Montana Medical Research
  • Women's Clinic of Lincoln, PC
  • Cooper University Hospital
  • Women's Health Research Center
  • Southwest Clinical Research
  • New Hanover Medical Research
  • Lyndhurst Gynecologic Associates
  • HWC Women's Research Center
  • Promedica Health System
  • Ilumina Clinical Associates
  • Medical Research South
  • Greenville Hospital System
  • Magnolia OB/GYN Research Center
  • Practice Research Organization
  • Centex Research
  • Bexar Clinical Trials
  • R/D Clinical Research, Inc.
  • Eastern Va Medical School
  • VCU Health Systems, MCV
  • Valley Women's Clinic
  • Ponce School of Medicine
  • Henry Rodriguez-Ginorio, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BGS649 co-administered with Levora 28™

Placebo co-administered with Levora 28™

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 3, 2010
Last Updated
November 3, 2020
Sponsor
Mereo BioPharma
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01116440
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
April 15, 2010 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
March 21, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mereo BioPharma
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain Associated With Refractory Endometriosis
Keywords
Menstrual pain, Refractory endometriosis, Pelvic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGS649 co-administered with Levora 28™
Arm Type
Experimental
Arm Title
Placebo co-administered with Levora 28™
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BGS649
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores
Description
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.
Time Frame
4 weeks
Title
Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score
Description
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.
Time Frame
12 weeks
Title
Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores
Description
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.
Time Frame
8 weeks
Title
Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Parkin, PhD FRCP
Organizational Affiliation
Mereo BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Northeast Arkansas Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Center for Fertility and Women's Health
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Zasa Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
University of Miami School of Medicine & Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
West Broward OB/GYN Associates
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Comprehensive Clinical Trials,LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Associated Pharmaceutical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Legacy Obstetrics & Gynecology
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
Minority Clinical Research Center of Atlanta
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Christie Clinic
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Women's Health Practice Center
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
The Advanced Gynecologic Surgery Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Cypress Medical Research Center, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Green Clinic, LLC
City
Ruston
State/Province
Louisiana
ZIP/Postal Code
71270
Country
United States
Facility Name
NECCR
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Saginaw Valley Medical Research Group, LLC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Women's Health Research Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Southwest Clinical Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New Hanover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Lyndhurst Gynecologic Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
HWC Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Promedica Health System
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Ilumina Clinical Associates
City
Hopwood
State/Province
Pennsylvania
ZIP/Postal Code
15445
Country
United States
Facility Name
Medical Research South
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
26905
Country
United States
Facility Name
Magnolia OB/GYN Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Practice Research Organization
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Centex Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Bexar Clinical Trials
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Eastern Va Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
VCU Health Systems, MCV
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Valley Women's Clinic
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Ponce School of Medicine
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Henry Rodriguez-Ginorio, MD
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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