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

NCT ID: NCT00958334

Last Updated: 2019-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-07

Study Completion Date

2008-10-15

Brief Summary

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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.

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Detailed Description

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ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Conditions

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Uterine Fibroids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proellex 25 mg

Two Proellex® 12.5 mg capsules once daily

Group Type EXPERIMENTAL

Proellex®

Intervention Type DRUG

25 mg daily (two 12.5 mg capsules)

Proellex 12.5 mg

One Proellex® 12.5 mg capsules once daily

Group Type EXPERIMENTAL

Proellex®

Intervention Type DRUG

25 mg daily (two 12.5 mg capsules)

Placebo

Capsule once a day

Group Type PLACEBO_COMPARATOR

Proellex®

Intervention Type DRUG

25 mg daily (two 12.5 mg capsules)

Interventions

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Proellex®

25 mg daily (two 12.5 mg capsules)

Intervention Type DRUG

Other Intervention Names

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CDB-4124 telapristone acetate

Eligibility Criteria

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Exclusion Criteria

* Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
* Pregnant or breastfeeding.
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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Anna Chan

Role: STUDY_DIRECTOR

Allergan

Locations

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Women's Health Research

Phoenix, Arizona, United States

Site Status

Arizona Wellness Centre for Women

Phoenix, Arizona, United States

Site Status

Medical Centre for Clinical Research

San Diego, California, United States

Site Status

Women's Health Care, Inc.

San Diego, California, United States

Site Status

Downtown Women's Health Care

Denver, Colorado, United States

Site Status

Insignia Clinical Research (Tampa Bay Women's Center)

Tampa, Florida, United States

Site Status

Affiliated Clinical Research, Inc.

Las Vegas, Nevada, United States

Site Status

SC Clinical Research Center

Columbia, South Carolina, United States

Site Status

Advances in Health Inc.

Houston, Texas, United States

Site Status

Obstetrical & Gynecolgical Associates, PA (OGA)

Houston, Texas, United States

Site Status

Women's Clinical Research Centre

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ZPU-003 Ext

Identifier Type: -

Identifier Source: org_study_id

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