The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
67
1 capsule daily for 4 months
1 capsule daily for 4 months
2 capsules daily for 4 months
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
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
Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
Time frame: monthly
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time frame: days
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time frame: days
The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits
Time frame: days
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