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

November 3, 2020 updated by: Mereo BioPharma

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores
Time Frame: 4 weeks
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
Time Frame: 12 weeks
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
Time Frame: 8 weeks
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
Time Frame: 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mereo BioPharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBGS649A2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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