Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

Phase 2 Completed 58 enrolled Bayer

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

Timeline

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

Publications

Junge W, Mellinger U, Parke S, Serrani M. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clin Drug Investig. 2011;31(8):573-584. doi: 10.2165/11590220-000000000-00000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	3 mg	Oral
Comparator	Levonorgestrel	Small molecule	0.125 mg	Oral
Subject	estradiol valerate	Unknown	2 mg	Oral
Comparator	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.