Clinical trial · Interventional
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
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
NCT00958334CI-TRIAL-00039112completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proellex® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Proellex 25 mg
- description
- Two Proellex® 12.5 mg capsules once daily
- interventionNames
- Drug: Proellex®
- type
- EXPERIMENTAL
- label
- Proellex 12.5 mg
- description
- One Proellex® 12.5 mg capsules once daily
- interventionNames
- Drug: Proellex®
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Capsule once a day
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.