Birth Control Patch Study

Phase 3 Completed 393 enrolled Bayer Parexel · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.

Timeline

Start: 2009-05
Primary completion: 2010-09
Completion: 2010-09

Publications

Gruber D, Skrivanek A, Serrani M, Lanius V, Merz M. A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study. Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gestodene	Small molecule	2.1 mg	Other
Subject	ethinyl estradiol	Small molecule	0.55 mg	Other
Subject	ethinyl estradiol	Small molecule	0.6 mg	Other
Comparator	norelgestromin	Unknown	6 mg	Other

Indications

No indication recorded.