Clinical trial · Interventional
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
A Phase 2, Multi-Center, Extension Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
NCT01739621CI-TRIAL-00014270completedPhase 2ClinicalTrials.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)
To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proellex 12 mg | Drug | — | UNRESOLVED |
| Proellex 24 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proellex 12 mg
- description
- Telapristone acetate, 1 vaginally inserted capsule, once a day, for 4 months
- interventionNames
- Drug: Proellex 12 mg
- type
- EXPERIMENTAL
- label
- Proellex 24 mg
- description
- Telapristone acetate, 1 vaginally inserted capsule, twice a day, for 4 months
- interventionNames
- Drug: Proellex 24 mg
Primary outcomes (2)
- measure
- Bleeding Days
- timeFrame
- 4 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 47 Years
Show eligibility criteria text
Inclusion Criteria: * Have a negative pregnancy test at the Baseline visit * Subject has successfully completed ZPV-200 and demonstrated a return of menses Exclusion Criteria: * Women with abnormally high liver enzymes or liver disease. Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) exceeding 1.5x upper limit normal (ULN AND)total bilirubin exceeding 1.5x ULN at baseline and confirmed on repeat). * Clinically significant abnormal findings on baseline examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
References
Publications (0)
Data not yet available
No reference posted for this study.