Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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

NCT00735553

Run by

Repros Therapeutics Inc.

People needed

77

Starts

2008-08-01

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

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Women's Health Research — Phoenix, Arizona, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Women's Health Care at Frost Steet — San Diego, 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
• Miami Research Associates — Miami, Florida, United States
• Insignia Clinical Research — Tampa, Florida, United States
• SC Clinical Research Center — Columbia, South Carolina, United States
• Advanced Research Associates — Corpus Christi, Texas, United States
• Advances in Health Inc. — Houston, Texas, United States
• The Woman's Hospital of Texas, Clinical Research Center — Houston, Texas, United States
• Institute for Women's Health — San Antonio, Texas, United States
• Seven Oaks Women's Ctr. — San Antonio, 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.