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

Clinical Trial, Phase I Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial, Phase I

Clinical Trial Details

NCT number	NCT02262663
Study type	Interventional
Source	Bayer
Contact
Status	Completed
Phase	Phase 1
Start date	October 2014
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02456129` - Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan	Phase 1
Completed	`NCT03402438` - Renal Impairment Study	Phase 1
Completed	`NCT03484585` - Rogaratinib (BAY1163877) Human Mass Balance Study	Phase 1
Active, not recruiting	`NCT04375267` - 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours	Phase 1