Pelvic Pain Associated With Refractory Endometriosis Clinical Trial
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
| Verified date | November 2020 |
| Source | Mereo BioPharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 27 |
| Est. completion date | March 21, 2012 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Ponce School of Medicine | Ponce | |
| Puerto Rico | Henry Rodriguez-Ginorio, MD | San Juan | |
| United States | Southwest Clinical Research | Albuquerque | New Mexico |
| United States | Zasa Clinical Research | Boynton Beach | Florida |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | Christie Clinic | Champaign | Illinois |
| United States | Women's Health Practice Center | Champaign | Illinois |
| United States | Medical Research South | Charleston | South Carolina |
| United States | Women's Medical Research Group, LLC | Clearwater | Florida |
| United States | Practice Research Organization | Dallas | Texas |
| United States | Associated Pharmaceutical Research | Decatur | Georgia |
| United States | Legacy Obstetrics & Gynecology | Decatur | Georgia |
| United States | Wayne State University | Detroit | Michigan |
| United States | HWC Women's Research Center | Englewood | Ohio |
| United States | NECCR | Fall River | Massachusetts |
| United States | Greenville Hospital System | Greenville | South Carolina |
| United States | Ilumina Clinical Associates | Hopwood | Pennsylvania |
| United States | Centex Research | Houston | Texas |
| United States | Bexar Clinical Trials | Irving | Texas |
| United States | Northeast Arkansas Clinic | Jonesboro | Arkansas |
| United States | R/D Clinical Research, Inc. | Lake Jackson | Texas |
| United States | Women's Clinic of Lincoln, PC | Lincoln | Nebraska |
| United States | University of Miami School of Medicine & Clinics | Miami | Florida |
| United States | Montana Medical Research | Missoula | Montana |
| United States | University of South Alabama Medical Center | Mobile | Alabama |
| United States | Magnolia OB/GYN Research Center | Myrtle Beach | South Carolina |
| United States | The Advanced Gynecologic Surgery Institute | Naperville | Illinois |
| United States | Center for Fertility and Women's Health | New Britain | Connecticut |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Eastern Va Medical School | Norfolk | Virginia |
| United States | Precision Trials | Phoenix | Arizona |
| United States | Women's Health Research Center | Plainsboro | New Jersey |
| United States | West Broward OB/GYN Associates | Plantation | Florida |
| United States | Valley Women's Clinic | Renton | Washington |
| United States | VCU Health Systems, MCV | Richmond | Virginia |
| United States | Minority Clinical Research Center of Atlanta | Riverdale | Georgia |
| United States | Green Clinic, LLC | Ruston | Louisiana |
| United States | Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan |
| United States | Promedica Health System | Toledo | Ohio |
| United States | Comprehensive Clinical Trials,LLC | West Palm Beach | Florida |
| United States | Cypress Medical Research Center, LLC | Wichita | Kansas |
| United States | Heartland Research Associates, LLC | Wichita | Kansas |
| United States | New Hanover Medical Research | Wilmington | North Carolina |
| United States | Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Mereo BioPharma | Novartis |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |