Clinical trial NCT00735553: Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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: 2008-08-15
Enrollment: 77
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: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: San Diego
country: United States
facility: Women's Health Care at Frost Steet
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Leesburg
country: United States
facility: OB-GYN Associates of Mid-Florida, P.A.
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Tampa
country: United States
facility: Insignia Clinical Research
state: Florida
city: Columbia
country: United States
facility: SC Clinical Research Center
state: South Carolina
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Houston
country: United States
facility: Advances in Health Inc.
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas, Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Institute for Women's Health
state: Texas
city: San Antonio
country: United States
facility: Seven Oaks Women's Ctr.
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAs, MD, PhD
role: STUDY_DIRECTOR
References: