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

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

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Proellex 25 mg
* Drug: Placebo
* Drug: Proellex 50 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo once daily | Drug: Placebo<br>* 1 capsule daily for 4 months<br>|
| Experimental: 25 mg<br>Proellex 25 mg once daily | Drug: Proellex 25 mg<br>* 1 capsule daily for 4 months<br>|
| Experimental: 50 mg<br>Proellex 50 mg once daily | Drug: Proellex 50 mg<br>* 2 capsules daily for 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Pelvic pain, Oral progesterone blocker