Comparative Cycle Control Europe

Phase 3 Completed 798 enrolled Bayer

RandomizedParallel-groupDouble-blindPrevention

Summary

The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

Timeline

Start: 2005-03
Primary completion: —
Completion: 2006-09

Publications

Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	3 mg	Oral
Comparator	Levonorgestrel	Small molecule	0.1 mg	Oral
Subject	estradiol valerate	Unknown	2 mg	Oral
Comparator	ethinyl estradiol	Small molecule	0.02 mg	Oral

Indications

No indication recorded.