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

PHASE1CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

July 17, 2017

Primary Completion Date

June 21, 2018

Study Completion Date

January 23, 2019

Conditions
Clinical Trial ,Phase I
Interventions
DRUG

Vilaprisan (BAY 1002670)

Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.

DRUG

Vilaprisan Placebo

Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.

DRUG

Microgynon

Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)

DRUG

Microgynon Placebo

For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).

Trial Locations (2)

10115

Dinox GmbH Berlin, Berlin

13353

CRS Clinical Research Services Berlin GmbH, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY