Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

NCT ID: NCT00737282

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-08-31

Brief Summary

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Detailed Description

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

25 mg Proellex

Proellex 25 mg once daily

Group Type: ACTIVE_COMPARATOR

Proellex 25 mg

Intervention Type: DRUG

One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Proellex 50 mg

Proellex 50 mg once daily

Group Type: ACTIVE_COMPARATOR

Proellex 50 mg

Intervention Type: DRUG

Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Interventions

Proellex 25 mg

One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Intervention Type: DRUG

Proellex 50 mg

Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Intervention Type: DRUG

Other Intervention Names

Telapristone acetate; 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

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

AWC Clinical Trials LLC

Little Rock, Arkansas, United States

Impact Clinical Trials

Beverly Hills, California, United States

Genesis Center for Clinical Research

San Diego, California, United States

Physician Care Clinical Research, LLC

Sarasota, Florida, United States

Atlanta Women's Research Inst

Atlanta, Georgia, United States

Medical Network for Education and Research

Decatur, Georgia, United States

Soapstone Center for Clinical Research

Decatur, Georgia, United States

York Clinical Consulting

Marrero, Louisiana, United States

NECCR Falls River LLC

Fall River, Massachusetts, United States

ClinSite, LLC

Ann Arbor, Michigan, United States

Female Pelvic Medicine

Grand Rapids, Michigan, United States

Alegent Research

Omaha, Nebraska, United States

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, United States

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Clinical Trials of America

Eugene, Oregon, United States

Thomas Jefferson University - Jefferson Center for Women's Medical Specialties

Philadelphia, Pennsylvania, United States

University Medical Group, Dept of OB/GYN

Greenville, South Carolina, United States

Greenville Pharmaceutical Research

Greenville, South Carolina, United States

Memphis Women's Healthcare

Memphis, Tennessee, United States

Women's Care Center, PLC Research Memphis Associates

Memphis, Tennessee, United States

Meharry Medical College

Nashville, Tennessee, United States

Women Partners in Health

Austin, Texas, United States

Willowbend Health & Wellness Associates

Plano, Texas, United States

Medical Associates Inc.

Menomonee Falls, Wisconsin, United States

Countries

United States

Other Identifiers

ZPU-305

Identifier Type: -

Identifier Source: org_study_id