drugset / Trial / NCT00702702
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
RandomizedParallel-groupDouble-blindTreatment
Summary
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-08
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telapristone Acetate | Other / unclassified | 25 mg | — |
| Subject | Telapristone Acetate | Other / unclassified | 50 mg | — |