Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
Launched by REPROS THERAPEUTICS INC. · Aug 12, 2009
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
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 inte...
Gender
FEMALE
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.
About Repros Therapeutics Inc.
Repros Therapeutics Inc. is a biopharmaceutical company focused on the development of innovative therapies for unmet medical needs in women's health and men's health. The company specializes in the advancement of treatments for conditions such as hormonal disorders and reproductive health issues. By leveraging cutting-edge research and clinical expertise, Repros aims to deliver effective and safe therapeutic options that enhance the quality of life for patients. With a commitment to scientific excellence and patient-centered care, Repros Therapeutics is dedicated to driving forward the next generation of healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
San Diego, California, United States
Denver, Colorado, United States
Tampa, Florida, United States
Columbia, South Carolina, United States
Houston, Texas, United States
Phoenix, Arizona, United States
San Diego, California, United States
Las Vegas, Nevada, United States
Houston, Texas, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Anna Chan
Study Director
Allergan
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials