FC Patch Low: Metabolism Study

Phase 2 Completed 30 enrolled Bayer

RandomizedCrossoverOpen-labelPrevention

Summary

The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.

Timeline

Start: 2009-06
Primary completion: 2010-09
Completion: 2010-09

Publications

Results Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gestodene	Small molecule	2.1 mg	Other
Comparator	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.03 mg	Other
Subject	ethinyl estradiol	Small molecule	0.55 mg	Other

Indications

No indication recorded.