NCT00556075TerminatedPhase 2
A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
Repros Therapeutics Inc.17 sites in 1 country67 target enrollmentStarted: November 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Repros Therapeutics Inc.
- Enrollment
- 67
- Locations
- 17
- Primary Endpoint
- Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Study Overview
Brief Summary
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 monitoring kit (for timing of endometrial biopsy)
- •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
- •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
Arms & Interventions
Placebo
Placebo Comparator
Placebo once daily
Intervention: Placebo (Drug)
25 mg
Experimental
Proellex 25 mg once daily
Intervention: Proellex 25 mg (Drug)
50 mg
Experimental
Proellex 50 mg once daily
Intervention: Proellex 50 mg (Drug)
Outcomes
Primary Outcomes
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time Frame: 4 months
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time Frame: 4 months
Secondary Outcomes
- 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)
Investigators
Study Sites (17)
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