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Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

NCT00958334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-06-18

Study results available
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Summary

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Proellex®

25 mg daily (two 12.5 mg capsules)

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Anna Chan · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-09-07
Primary Completion
2008-10-15
Completion
2008-10-15

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 NCT00958334 on ClinicalTrials.gov