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

Phase 3

Terminated

• Conditions: Uterine Fibroids; Anemia
• Interventions: Drug: Placebo; Drug: Proellex 25 mg; Drug: Proellex 50 mg

• Registration Number: NCT00702702
• Lead Sponsor: Repros Therapeutics Inc.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2014-06-23
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Results First Posted: 2014-08-21
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C Placebo	Placebo	Placebo, 2 capsules daily for 3 months
A 25 mg	Proellex 25 mg	Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
B 50 mg	Proellex 50 mg	Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin vs Placebo	3 months	Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3

Trial Locations

Locations (29)

Central Brooklyn Medical Group (eCast); 🇺🇸 Brooklyn, New York, United States

Phoenix Women's Center (eCast); 🇺🇸 College Park, Georgia, United States

Advanced Research Associates; 🇺🇸 Corpus Christi, Texas, 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

Comprehensive Clinical Trials, LLC; 🇺🇸 West Palm Beach, Florida, United States

Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast); 🇺🇸 Decatur, Georgia, United States

Medical Network for Education and Research; 🇺🇸 Decatur, Georgia, 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

Centex Research; 🇺🇸 Houston, Texas, United States

Advances in Health Inc.; 🇺🇸 Houston, Texas, United States

Institute for Women's Health; 🇺🇸 San Antonio, Texas, United States

Downtown Women's Health Care; 🇺🇸 Denver, Colorado, United States

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Women's Health Research; 🇺🇸 Phoenix, Arizona, United States

Segal Institute for Clinical Research; 🇺🇸 Miami, Florida, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

OB-GYN Associates of Mid-Florida, P.A.; 🇺🇸 Leesburg, Florida, United States

Insignia Clinical Research (Tampa Bay Women's Center); 🇺🇸 Tampa, Florida, United States

Clinical Trials Select (ecast); 🇺🇸 Silver Spring, Maryland, United States

Smith & Hackney; 🇺🇸 Morrow, Georgia, United States

Bluegrass Clinical Research, Inc.; 🇺🇸 Louisville, Kentucky, United States

SC Clinical Research Center; 🇺🇸 Columbia, South Carolina, United States

The Women's Hospital of Texas, Clinical Research Center; 🇺🇸 Houston, Texas, United States

Seven Oaks Women's Center; 🇺🇸 San Antonio, Texas, United States

Phoenix OB-GYN Associates, LLC; 🇺🇸 Moorestown, New Jersey, United States