Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT00853567

Run by

Repros Therapeutics Inc.

People needed

71

Starts

2009-02-01

Expected to finish

2009-08-01

Last updated by the study team

2014-08-21

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Impact Clinical Trials — Los Angeles, California, United States
• Segal Institute for Clinical Research — Miami, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Phoenix Women's Center (eCast0 — 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 (eCast) — Morrow, Georgia, United States
• Bluegrass Clinical Research, Inc. — Louisville, Kentucky, 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
• Chattanooga Medical Research, LLC — Chattanooga, Tennessee, United States
• Center for Women's Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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