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

NCT00882258 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2014-07-08

No results posted yet for this study

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.

Conditions

  • Uterine Fibroids

Interventions

DRUG

12.5 mg Proellex

12.5 mg Proellex administered orally daily

DRUG

25 mg Proellex

25 mg Proellex administered orally daily

DRUG

Placebo

Administered orally daily

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00882258 on ClinicalTrials.gov