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

Uterine Fibroids Clinical Trial

Official title:

A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958334
• Other study ID #: ZPU-003 Ext
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

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