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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Uterine Fibroids, Anemia

In brief

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.

Key facts

Study ID

NCT00702702

Run by

Repros Therapeutics Inc.

People needed

56

Starts

2008-06-01

Expected to finish

2009-08-01

Last updated by the study team

2014-08-21

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Depo-Provera use must cease ten months prior to first dose of study drug, or
• GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
• Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.