drugset / Trial / NCT03210246

Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)

NCT03210246

Phase 1 Completed 71 enrolled Bayer
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

EvaluationDrugModalityDoseRoute
Subject Microgynon Unknown
Subject Vilaprisan Other / unclassified

Indications

No indication recorded.