drugset / Trial / NCT00735553
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
RandomizedParallel-groupDouble-blindTreatment
Summary
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-08
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Telapristone Acetate | Other / unclassified | 25 mg | Oral |
| Comparator | Telapristone Acetate | Other / unclassified | 50 mg | Oral |