Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Endometriosis

In brief

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.

Key facts

Study ID

NCT00556075

Run by

Repros Therapeutics Inc.

People needed

67

Starts

2007-11-01

Expected to finish

2009-07-01

Last updated by the study team

2014-08-25

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Premenopausal women aged 18-48 inclusive
• Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
• Clinical symptoms of endometriosis for at least the past three (3) months
• Endometriosis symptoms
• Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
• Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
• Other inclusion criteria may apply

You may not qualify if…

• Six (6) months or more without a menstrual period, or
• Prior hysterectomy or
• Prior bilateral oophorectomy
• Diagnosis of osteopenia
• Present history or condition that causes non-endometriosis-related dyspareunia
• Presence of excessive bleeding or menorrhagia
• Abnormal screening endometrial biopsy
• Other exclusion criteria may apply

Where it is running

• Advanced Clinical Therapeutics, LLC — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Compass Clinical Research — San Ramon, California, United States
• Altus Research — Lake Worth, Florida, United States
• Comprehensive Clinical Trials — West Palm Beach, Florida, United States
• Medical Associates — Dubuque, Iowa, United States
• Physicians for Women — Cary, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Rapid Medical Research, Inc. — Cleveland, Ohio, United States
• HWC Women's Research Center — Miamisburg, Ohio, United States
• SC Clinical Research Center, LLC — Columbia, South Carolina, United States
• Gaffney Pharmaceutical Research — Gaffney, South Carolina, United States
• Greenville Pharma Research — Greenville, South Carolina, United States
• Advanced Research Associates — Corpus Christi, Texas, United States
• Clinical Trials of Texas/Institute for Women's Health — San Antonio, Texas, United States
• Clinical Trials of Texas/Seven Oaks Women's Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.