Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
- Conditions
- Endometriosis
- Interventions
- Drug: Proellex 25 mgDrug: Proellex 50 mgDrug: Placebo
- Registration Number
- NCT00556075
- Lead Sponsor
- Repros Therapeutics Inc.
- Brief Summary
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 67
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 25 mg Proellex 25 mg Proellex 25 mg once daily 50 mg Proellex 50 mg Proellex 50 mg once daily Placebo Placebo Placebo once daily
- Primary Outcome Measures
Name Time Method Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score 4 months Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score 4 months
- Secondary Outcome Measures
Name Time Method Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits monthly Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries days Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries days The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits days
Trial Locations
- Locations (17)
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Medical Associates
🇺🇸Dubuque, Iowa, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Clinical Trials of Texas/Institute for Women's Health
🇺🇸San Antonio, Texas, United States
Comprehensive Clinical Trials
🇺🇸West Palm Beach, Florida, United States
Advanced Clinical Therapeutics, LLC
🇺🇸Tucson, Arizona, United States
HWC Women's Research Center
🇺🇸Miamisburg, Ohio, United States
Physicians for Women
🇺🇸Cary, North Carolina, United States
Compass Clinical Research
🇺🇸San Ramon, California, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Clinical Trials of Texas/Seven Oaks Women's Center
🇺🇸San Antonio, Texas, United States
Greenville Pharma Research
🇺🇸Greenville, South Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Gaffney Pharmaceutical Research
🇺🇸Gaffney, South Carolina, United States
SC Clinical Research Center, LLC
🇺🇸Columbia, South Carolina, United States
Advanced Research Associates
🇺🇸Corpus Christi, Texas, United States