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

Phase 2

Completed

• Conditions: Uterine Fibroids
• Interventions: Drug: 12.5 mg Proellex; Drug: Placebo; Drug: 25 mg Proellex

• Registration Number: NCT00882258
• Lead Sponsor: Repros Therapeutics Inc.

Brief Summary

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.

Detailed Description

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. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-16
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• 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

Exclusion Criteria

• Post-menopausal women, as defined as one or more of the following:

  1. six months or more (immediately prior to Screening visit) without a menstrual period, or
  2. prior hysterectomy and/or oophorectomy

• Subjects with documented endometriosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12.5 mg Proellex	12.5 mg Proellex	Proellex 12.5 mg daily
Placebo	Placebo	Placebo daily
25 mg Proellex daily	25 mg Proellex	Proellex 25 mg

Primary Outcome Measures

Name	Time	Method
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata	91 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata	91 days

Trial Locations

Locations (16)

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

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