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Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

NCT00874302 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-06-27

No results posted yet for this study

Summary

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Proellex

One 25mg capsule taken orally once every day.

DRUG

Proellex

Two 25mg capsules Proellex (50mg) taken orally once every day

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Andre van As, MD, PhD · Repros Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Brazil

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 NCT00874302 on ClinicalTrials.gov