Status:
COMPLETED
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 doub...
Eligibility Criteria
Inclusion
- Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.
Exclusion
- Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
September 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00958334
Start Date
September 7 2006
End Date
October 15 2008
Last Update
June 18 2019
Active Locations (11)
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1
Women's Health Research
Phoenix, Arizona, United States, 85015
2
Arizona Wellness Centre for Women
Phoenix, Arizona, United States, 85032
3
Medical Centre for Clinical Research
San Diego, California, United States, 92108
4
Women's Health Care, Inc.
San Diego, California, United States, 92123