Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

Phase 2 Completed 29 enrolled Bayer

RandomizedCrossoverOpen-labelPrevention

Summary

The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

Timeline

Start: 2006-04
Primary completion: 2007-05
Completion: 2007-05

Publications

Results Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Drugs R D. 2011;11(2):159-70. doi: 10.2165/11591200-000000000-00000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	3 mg	Oral
Subject	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	estradiol valerate	Unknown	2 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.