Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)

Phase 3 Completed 121 enrolled Organon and Co

RandomizedParallel-groupOpen-labelPrevention

Summary

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.

Timeline

Start: 2006-10
Primary completion: 2008-01
Completion: 2008-01

Publications

Results Agren UM, Anttila M, Maenpaa-Liukko K, Rantala ML, Rautiainen H, Sommer WF, Mommers E. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism. Eur J Contracept Reprod Health Care. 2011 Dec;16(6):444-57. doi: 10.3109/13625187.2011.604450.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Estradiol	Other / unclassified	1.5 mg	Oral
Comparator	Levonorgestrel	Small molecule	150 ug	Oral
Subject	Nomegestrol Acetate	Small molecule	2.5 mg	Oral
Comparator	ethinyl estradiol	Small molecule	30 ug	Oral

Indications

No indication recorded.