Clinical trial · Interventional
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
NCT01069120CI-TRIAL-00015433terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Repros stopped study due to safety and FDA placed study on hold
Summary
Brief summary (as posted)
Safety and efficacy study of 25 and 50 mg doses of Proellex
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 (2)
- type
- ACTIVE_COMPARATOR
- label
- 50 mg Proellex®
- description
- 2, 25 mg capsules
- interventionNames
- Drug: Proellex
- type
- ACTIVE_COMPARATOR
- label
- 25 mg Proellex®
- description
- 1, 25 mg capsule
- interventionNames
- Drug: Proellex
Primary outcomes (1)
- measure
- To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
- timeFrame
- During two 4 month treatment periods
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU) * Subject has a menstrual cycle lasting from 20 to 40 days. * Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304 Exclusion Criteria: * Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304. * Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
References
Publications (0)
Data not yet available
No reference posted for this study.