Phase 2
Completed N=65
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
Source: ClinicalTrials.gov NCT00958334 ↗Enrolled (actual)
65
Serious AEs
6.2%
Results posted
Jan 2011
Primary outcomePrimary: 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. — 136.29; 179.95; 130.86; -41.00 mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
136.29; 179.95; 130.86; -41.00; -63.57; -38.60 | — |
| SECONDARY 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) |
-150.67; -248.67; -654.00; -25.33; -230.00 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00958334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.