Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Completed · Phase 2 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Key facts

Study ID

NCT00882258

Run by

Repros Therapeutics Inc.

People needed

144

Starts

2006-03-01

Expected to finish

2007-03-01

Last updated by the study team

2014-07-08

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
• Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

You may not qualify if…

• Post-menopausal women, as defined as one or more of the following:
• six months or more (immediately prior to Screening visit) without a menstrual period, or
• prior hysterectomy and/or oophorectomy
• Subjects with documented endometriosis

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Women's Health Research — Phoenix, Arizona, United States
• Arizona Wellness Centre for Women — Phoenix, Arizona, United States
• Visions Clinical Research Tuscon — Tuscon, Arizona, United States
• Medical Centre for Clinical Research — San Diego, California, United States
• Women's Health Care, Inc. — San Diego, California, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Miami Research Associates, Women's Health Studies — Miami, Florida, United States
• Insignia Clinical Research (Tampa Bay Women's Center) — Tampa, Florida, United States
• Caring for Women — Las Vegas, Nevada, United States
• Affiliated Clinical Research, Inc. — Las Vegas, Nevada, United States
• SC Clinical Research Center — Columbia, South Carolina, United States
• Advances in Health Inc. — Houston, Texas, United States
• Obstetrical & Gynecolgical Associates, PA (OGA) — Houston, Texas, United States
• Women's Clinical Research Centre — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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