Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids

NCT ID: NCT00702702

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-08-31

Brief Summary

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Detailed Description

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Study was terminated by clinical hold.

Conditions

Uterine Fibroids; Anemia

Study Design

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

Study Groups

A 25 mg

Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

Group Type: EXPERIMENTAL

Proellex 25 mg

Intervention Type: DRUG

Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

B 50 mg

Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Group Type: EXPERIMENTAL

Proellex 50 mg

Intervention Type: DRUG

Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

C Placebo

Placebo, 2 capsules daily for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 2 capsules daily for 3 months

Interventions

Proellex 25 mg

Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

Intervention Type: DRUG

Proellex 50 mg

Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Intervention Type: DRUG

Placebo

Placebo, 2 capsules daily for 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
• Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
• Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
• Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria

• Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

• Six months or more (immediately prior to Screening Visit) without a menstrual period, or
• Prior hysterectomy, or
• Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
• Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
• Documented endometriosis or active pelvic inflammatory disease (PID);
• Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
• Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
• Use of prohibited concomitant medications:

1. Depo-Provera use must cease ten months prior to first dose of study drug, or

2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or

3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

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

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

Segal Institute for Clinical Research

Miami, Florida, United States

Insignia Clinical Research (Tampa Bay Women's Center)

Tampa, Florida, United States

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Phoenix Women's Center (eCast)

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

Morrow, Georgia, United States

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, United States

Clinical Trials Select (ecast)

Silver Spring, Maryland, United States

Phoenix OB-GYN Associates, LLC

Moorestown, New Jersey, 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

SC Clinical Research Center

Columbia, South Carolina, United States

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, United States

Advanced Research Associates

Corpus Christi, Texas, United States

Advances in Health Inc.

Houston, Texas, United States

The Women's Hospital of Texas, Clinical Research Center

Houston, Texas, United States

Centex Research

Houston, Texas, United States

Institute for Women's Health

San Antonio, Texas, United States

Seven Oaks Women's Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ZPU-301

Identifier Type: -

Identifier Source: org_study_id