At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
Proellex®drug
Likely dose
Proellex® 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Proellex® for Uterine Fibroids. Completed, enrolled 65 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
Primary CompletionOct 2008
First PostedAug 2009
TodayJul 2026
First PostedAug 13, 2009
Enrollment StartSep 7, 2006
Primary CompletionOct 15, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.9 years ago
Interventions
Proellex®drug
25 mg daily (two 12.5 mg capsules)