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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pelvic Pain Associated With Refractory Endometriosis

In brief

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

Key facts

Study ID

NCT01116440

Run by

Mereo BioPharma

People needed

27

Starts

2010-04-15

Expected to finish

2012-03-21

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• Precision Trials — Phoenix, Arizona, United States
• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Center for Fertility and Women's Health — New Britain, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Zasa Clinical Research — Boynton Beach, Florida, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• University of Miami School of Medicine & Clinics — Miami, Florida, United States
• West Broward OB/GYN Associates — Plantation, Florida, United States
• Comprehensive Clinical Trials,LLC — West Palm Beach, Florida, United States
• Associated Pharmaceutical Research — Decatur, Georgia, United States
• Legacy Obstetrics & Gynecology — Decatur, Georgia, United States
• Minority Clinical Research Center of Atlanta — Riverdale, Georgia, United States
• Christie Clinic — Champaign, Illinois, United States
• Women's Health Practice Center — Champaign, Illinois, United States
• The Advanced Gynecologic Surgery Institute — Naperville, Illinois, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Cypress Medical Research Center, LLC — Wichita, Kansas, United States
• Green Clinic, LLC — Ruston, Louisiana, United States
• NECCR — Fall River, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Saginaw Valley Medical Research Group, LLC — Saginaw, Michigan, United States
• Montana Medical Research — Missoula, Montana, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Cooper University Hospital — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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