Pharmacodynamic Characterization of Dienogest

Phase 1 Completed 102 enrolled Bayer

RandomizedParallel-groupDouble-blind

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.

Timeline

Start: 2008-09
Primary completion: 2009-07
Completion: 2009-09

Publications

Results Klipping C, Duijkers I, Remmers A, Faustmann T, Zurth C, Klein S, Schuett B. Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women. J Clin Pharmacol. 2012 Nov;52(11):1704-13. doi: 10.1177/0091270011423664. Epub 2011 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	0.5 mg	Oral
Subject	Dienogest	Small molecule	1 mg	Oral
Subject	Dienogest	Small molecule	2 mg	Oral
Subject	Dienogest	Small molecule	3 mg	Oral

Indications

No indication recorded.