Clinical trial NCT00853567: Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids
Official title: A Phase III, Three-Arm, Parallel Design, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 71
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: Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed description: Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Eligibility criteria: Inclusion Criteria:

* Speak, read and understand English or Spanish;
* Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
* One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
* Menstrual cycle lasting from 24 to 36 days;
* History of excessive menstrual bleeding;
* Negative urine pregnancy test at screening.

Exclusion Criteria:

* Six months or more (immediately prior to Screening Visit) without a menstrual period;
* Prior hysterectomy;
* Prior bilateral oophorectomy;
* Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
* Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
* Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
* Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
* Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Primary outcomes:
measure: To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Los Angeles
country: United States
facility: National Institute of Clinical Research
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: College Park
country: United States
facility: Phoenix Women's Center (eCast0
state: Georgia
city: Decatur
country: United States
facility: Clinical Trials Select (eCast)
state: Georgia
city: Decatur
country: United States
facility: Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
state: Georgia
city: Decatur
country: United States
facility: Medical Network for Education and Research
state: Georgia
city: Morrow
country: United States
facility: Smith & Hackney (eCast)
state: Georgia
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Brooklyn
country: United States
facility: Central Brooklyn Medical Group (eCast)
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc. (Elite)
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Houston
country: United States
facility: Center for Women's Medicine
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAs, MD, PhD
role: STUDY_DIRECTOR
References: