drugset / Trial / NCT02262663
Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan
RandomizedParallel-groupQuadruple-blind
Summary
This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-09
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vilaprisan | Other / unclassified | 0.5 mg | Oral |
| Subject | Vilaprisan | Other / unclassified | 1 mg | Oral |
| Subject | Vilaprisan | Other / unclassified | 2 mg | Oral |
| Subject | Vilaprisan | Other / unclassified | 4 mg | Oral |
Indications
No indication recorded.