Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
- Conditions
- Uterine Fibroids
- Interventions
- Drug: Proellex®
- Registration Number
- NCT00958334
- Lead Sponsor
- Repros Therapeutics Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
- Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.
- Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
- Pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proellex 25 mg Proellex® Two Proellex® 12.5 mg capsules once daily Proellex 12.5 mg Proellex® One Proellex® 12.5 mg capsules once daily Placebo Proellex® Capsule once a day
- Primary Outcome Measures
Name Time Method 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. Baseline to 17 months 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.
- Secondary Outcome Measures
Name Time Method 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) Baseline, 14 months, 17 months 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.
Trial Locations
- Locations (11)
Arizona Wellness Centre for Women
🇺🇸Phoenix, Arizona, United States
Medical Centre for Clinical Research
🇺🇸San Diego, California, United States
Women's Health Care, Inc.
🇺🇸San Diego, California, United States
Insignia Clinical Research (Tampa Bay Women's Center)
🇺🇸Tampa, Florida, United States
SC Clinical Research Center
🇺🇸Columbia, South Carolina, United States
Advances in Health Inc.
🇺🇸Houston, Texas, United States
Obstetrical & Gynecolgical Associates, PA (OGA)
🇺🇸Houston, Texas, United States
Women's Clinical Research Centre
🇺🇸Seattle, Washington, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Affiliated Clinical Research, Inc.
🇺🇸Las Vegas, Nevada, United States