Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

NCT ID: NCT00735553

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• 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 mg Proellex

25 mg oral daily dose of Proellex

Group Type: ACTIVE_COMPARATOR

Proellex

Intervention Type: DRUG

One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months

50 mg Proellex

50 mg oral daily dose of Proellex

Group Type: ACTIVE_COMPARATOR

Proellex

Intervention Type: DRUG

Two 25 mg mg capsules of Proellex® orally daily for up to four months

placebo

oral daily dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Two placebo capsules orally daily for up to four months

Interventions

Proellex

One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months

Intervention Type: DRUG

Proellex

Two 25 mg mg capsules of Proellex® orally daily for up to four months

Intervention Type: DRUG

Placebo

Two placebo capsules orally daily for up to four months

Intervention Type: DRUG

Other Intervention Names

Telapristone acetate; Telapristone acetate; Sugar pill

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

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Women's Health Research

Phoenix, Arizona, United States

Genova Clinical Research, Inc.

Tucson, Arizona, United States

Women's Health Care at Frost Steet

San Diego, California, United States

Downtown Women's Health Care

Denver, Colorado, United States

Visions Clinical Research

Boynton Beach, Florida, United States

OB-GYN Associates of Mid-Florida, P.A.

Leesburg, Florida, United States

Miami Research Associates

Miami, Florida, United States

Insignia Clinical Research

Tampa, Florida, United States

SC Clinical Research Center

Columbia, South Carolina, United States

Advanced Research Associates

Corpus Christi, Texas, United States

Advances in Health Inc.

Houston, Texas, United States

The Woman's Hospital of Texas, Clinical Research Center

Houston, Texas, United States

Institute for Women's Health

San Antonio, Texas, United States

Seven Oaks Women's Ctr.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ZPU-303

Identifier Type: -

Identifier Source: org_study_id