Clinical trial NCT00556075: Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
Pelvic pain
Oral progesterone blocker
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
timeFrame: 4 months
measure: Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
timeFrame: 4 months
Secondary outcomes:
measure: Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
timeFrame: monthly
measure: Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
timeFrame: days
measure: Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
timeFrame: days
measure: The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits
timeFrame: days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics, LLC
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Ramon
country: United States
facility: Compass Clinical Research
state: California
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials
state: Florida
city: Dubuque
country: United States
facility: Medical Associates
state: Iowa
city: Cary
country: United States
facility: Physicians for Women
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Miamisburg
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Columbia
country: United States
facility: SC Clinical Research Center, LLC
state: South Carolina
city: Gaffney
country: United States
facility: Gaffney Pharmaceutical Research
state: South Carolina
city: Greenville
country: United States
facility: Greenville Pharma Research
state: South Carolina
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas/Institute for Women's Health
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas/Seven Oaks Women's Center
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAs, MD, PhD
role: STUDY_DIRECTOR
References: