Clinical trial NCT00958334: Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline to 17 months
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 14 months, 17 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Wellness Centre for Women
state: Arizona
city: San Diego
country: United States
facility: Medical Centre for Clinical Research
state: California
city: San Diego
country: United States
facility: Women's Health Care, Inc.
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Tampa
country: United States
facility: Insignia Clinical Research (Tampa Bay Women's Center)
state: Florida
city: Las Vegas
country: United States
facility: Affiliated Clinical Research, Inc.
state: Nevada
city: Columbia
country: United States
facility: SC Clinical Research Center
state: South Carolina
city: Houston
country: United States
facility: Advances in Health Inc.
state: Texas
city: Houston
country: United States
facility: Obstetrical & Gynecolgical Associates, PA (OGA)
state: Texas
city: Seattle
country: United States
facility: Women's Clinical Research Centre
state: Washington
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: