drugset / Trial / NCT03210246
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
RandomizedParallel-groupQuadruple-blindOther
Summary
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
Timeline
- Start
- 2017-07-17
- Primary completion
- 2018-06-21
- Completion
- 2019-01-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Microgynon | Unknown | — | — |
| Subject | Vilaprisan | Other / unclassified | — | — |
Indications
No indication recorded.