Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

NCT ID: NCT00853567

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

25 g Proellex

25 mg oral daily dose of Proellex

Group Type: ACTIVE_COMPARATOR

Proellex

Intervention Type: DRUG

25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

50 mg Proellex

50 mg oral daily dose of Proellex

Group Type: ACTIVE_COMPARATOR

Proellex

Intervention Type: DRUG

25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

Placebo

Placebo treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Placebo

Interventions

Proellex

25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

Intervention Type: DRUG

placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

Telapristone acetate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Repros Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andre vanAs, MD, PhD

Role: STUDY_DIRECTOR

Repros Therapeutics Inc.

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

Impact Clinical Trials

Los Angeles, California, United States

National Institute of Clinical Research

Los Angeles, California, United States

Impact Clinical Trials

Los Angeles, California, United States

Segal Institute for Clinical Research

Miami, Florida, United States

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Phoenix Women's Center (eCast0

College Park, Georgia, United States

Clinical Trials Select (eCast)

Decatur, Georgia, United States

Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)

Decatur, Georgia, United States

Medical Network for Education and Research

Decatur, Georgia, United States

Smith & Hackney (eCast)

Morrow, Georgia, United States

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, United States

Central Brooklyn Medical Group (eCast)

Brooklyn, New York, United States

Rapid Medical Research, Inc. (Elite)

Cleveland, Ohio, United States

HWC Women's Research Center

Englewood, Ohio, United States

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, United States

Center for Women's Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

ZPU-304

Identifier Type: -

Identifier Source: org_study_id