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Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

NCT00735553 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2014-08-21

Study results available
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Summary

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Proellex

One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months

DRUG

Proellex

Two 25 mg mg capsules of Proellex® orally daily for up to four months

DRUG

Placebo

Two placebo capsules orally daily for up to four months

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

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 NCT00735553 on ClinicalTrials.gov