Status: Active, not recruiting
Purpose:
The purpose of this study is to determine whether Proellex® is safe and effective for the treatment of symptomatic endometriosis.
Eligibility:
Females, ages 18 years to 48 years
Inclusion Criteria:
- 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 kit
- Other inclusion criteria may apply
Exclusion Criteria:
- Six (6) months or more without a menstrual period, or
- Prior hysterectomy or
- Prior bilateral oophorectomy
- Diagnosis of osteopenia
- Presence of excessive bleeding or menorrhagia
- Abnormal screening endometrial biopsy
- Other exclusion criteria my apply
Study Drug:
Proellex 25mg, Proellex 50mg, and Placebo
Study Design:
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Controlled, Parallel Assignment, Safety/ Efficacy Study
Primary Outcome Measures:
- Difference between the 50mg Proellex group and placebo group in the subject diary composite pain score
- Difference between the 25 mg and 50mg Proellex groups and placebo group in the subject diary composite pain score
Secondary Outcome Measures:
- Difference between each treatment group in the subject diary composite pain score at the monthly visits
- Time to pain-free assessments using the composite pain score as determined by data recorded in the subject diaries
- Duration of pain-free assessments using the composite pain score as determined by data recorded in the subject diaries
- The number of days with pain as determined by data recorded in the subject diaries, analyzed between treatment groups at the monthly visits
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Study Director:
Andre van As, MD, PhD
Repros Therapeutics Inc.
If you meet the study criteria and are interested in participating in the study, please contact:
Study Manager:
John Weiler, MD
319-626-8888
jweiler@compleware.com
Current Clinical Site Locations:
For more information, please visit www.clinicaltrials.gov
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