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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00958334
Other study ID # ZPU-003 Ext
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 7, 2006
Est. completion date October 15, 2008

Study information

Verified date May 2019
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date October 15, 2008
Est. primary completion date October 15, 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.

Exclusion Criteria:

- Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.

- Pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Proellex®
25 mg daily (two 12.5 mg capsules)

Locations

Country Name City State
United States SC Clinical Research Center Columbia South Carolina
United States Downtown Women's Health Care Denver Colorado
United States Advances in Health Inc. Houston Texas
United States Obstetrical & Gynecolgical Associates, PA (OGA) Houston Texas
United States Affiliated Clinical Research, Inc. Las Vegas Nevada
United States Arizona Wellness Centre for Women Phoenix Arizona
United States Women's Health Research Phoenix Arizona
United States Medical Centre for Clinical Research San Diego California
United States Women's Health Care, Inc. San Diego California
United States Women's Clinical Research Centre Seattle Washington
United States Insignia Clinical Research (Tampa Bay Women's Center) Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data. Baseline to 17 months
Secondary Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood. Baseline, 14 months, 17 months
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