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Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

NCT00737282 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2014-08-21

Study results available
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Summary

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Proellex 25 mg

One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

DRUG

Proellex 50 mg

Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Andre vanAs, MD, PhD · Repros Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737282 on ClinicalTrials.gov