NCT00754871

Pharmacodynamic Characterization of Dienogest

A Double-blind, Randomized, Dose-controlled Study to Evaluate Pharmacodynamic Properties of Four Oral Doses of Dienogest (DNG) in 100 Healthy Young Female Volunteers Over a Period of Two Cycles up to a Maximum of 72 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.

Conditions

• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Dienogest (81150037)	daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days
DRUG	Dienogest (81150231)	daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days
DRUG	Dienogest (SH T00660A)	daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days
DRUG	Dienogest (81150746)	daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2008-09-18
• Last updated: 2015-01-27

Locations

1 site across 1 country: Netherlands