An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

NCT ID: NCT00958893

Last Updated: 2014-08-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed Description

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This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Conditions

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Uterine Fibroids

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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25 mg Proellex

25 mg Proellex daily

Group Type EXPERIMENTAL

25 mg Proellex

Intervention Type DRUG

one 25 mg capsules

Interventions

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25 mg Proellex

one 25 mg capsules

Intervention Type DRUG

Other Intervention Names

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CDB-4124 Proellex

Eligibility Criteria

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Inclusion Criteria

* Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion Criteria

* All other subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Repros Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andre van As, MD, PhD

Role: STUDY_DIRECTOR

Repros Therapeutics Inc.

Locations

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Advances in Health, Inc.

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ZPU-003 Extension 2

Identifier Type: -

Identifier Source: org_study_id

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