drugset / Trial / NCT01451424
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
RandomizedParallel-groupSingle-blindTreatment
Summary
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
Timeline
- Start
- 2012-02
- Primary completion
- 2012-12
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telapristone Acetate | Other / unclassified | 3 mg | Other |
| Subject | Telapristone Acetate | Other / unclassified | 6 mg | Other |
| Subject | Telapristone Acetate | Other / unclassified | 12 mg | Other |
| Subject | Telapristone Acetate | Other / unclassified | 24 mg | Other |