Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

August 5, 2014 updated by: Repros Therapeutics Inc.

A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Safety and efficacy study of 25 and 50 mg doses of Proellex

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Tampa, Florida, United States, 33067
        • Insignia Clinical Research (Tampa Bay Women's Center)
    • Texas
      • Houston, Texas, United States, 77030
        • Advances In Health Inc
      • Houston, Texas, United States, 77054
        • The Women's Hospital of Texas, Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
  • Subject has a menstrual cycle lasting from 20 to 40 days.
  • Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

  • Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
  • Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 50 mg Proellex®
2, 25 mg capsules
Drug: Proellex
2, 25 mg capsules once per day
Other Names:
  • CDB-4124
Drug: Proellex
1, 25 mg capsule once per day
Other Names:
  • CDB-4124
Active Comparator: 25 mg Proellex®
1, 25 mg capsule
Drug: Proellex
2, 25 mg capsules once per day
Other Names:
  • CDB-4124
Drug: Proellex
1, 25 mg capsule once per day
Other Names:
  • CDB-4124

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Time Frame: During two 4 month treatment periods
During two 4 month treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Investigators

  • Study Director: Andre VanAs, PhD, MD, Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPU-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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