Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

NCT00567164 ↗

Phase 3 Completed 1887 enrolled Bayer

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine whether the study drug is safe and effective.

Timeline

Start: 2007-10
Primary completion: 2009-11
Completion: 2009-11

Outcome

Met primary endpoint

paper subjects in the flexible(MIB) group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). PMID 22281416 ↗

Publications

Results Jensen JT, Garie SG, Trummer D, Elliesen J. Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception. 2012 Aug;86(2):110-8. doi: 10.1016/j.contraception.2011.12.009. Epub 2012 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	drospirenone	Unknown	3 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.02 mg	Oral