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

NCT03210246 PHASE1 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	PHASE1
Status	COMPLETED
Enrolment	71
Start date	Mon Jul 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jan 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Clinical Trial ,Phase I

Interventions

• Vilaprisan (BAY 1002670)
• Vilaprisan Placebo
• Microgynon
• Microgynon Placebo

Countries

Germany