NCT02262663

Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan

A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clinical Trial, Phase I

Interventions

Type	Name	Description
DRUG	Vilaprisan (BAY1002670)

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-10-13
• Last updated: 2016-03-16

Locations

2 sites across 1 country: Germany