drugset / Trial / NCT00737282
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
RandomizedParallel-groupOpen-labelTreatment
Summary
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-08
- Completion
- 2009-08
Outcome
Outcome not reported
Stopped: “Repros stopped study for safety and FDA put study on hold.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Proellex | Other / unclassified | 25 mg | Oral |
| Comparator | Proellex | Other / unclassified | 50 mg | Oral |