NCT01816815

Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in 60 Healthy Tubal-ligated Women Aged 18 to 45 Years Investigating the Pharmacodynamic Effects of 5 Different Doses (0.1 - 5 mg) BAY1002670 After Daily Oral Administration Over 84 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	BAY1002670
DRUG	Placebo

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2013-03-22
• Last updated: 2014-04-21

Locations

6 sites across 3 countries: Belgium, Germany, United Kingdom