A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)

Phase 1 Completed 25 enrolled Organon and Co CRS Mannheim GmbH · collab

RandomizedParallel-groupDouble-blindOther

Summary

The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2

Timeline

Start: 2007-05-01
Primary completion: 2007-09-01
Completion: 2007-09-01

Publications

Results Gerrits MG, Schnabel PG, Post TM, Peeters PA. Pharmacokinetic profile of nomegestrol acetate and 17beta-estradiol after multiple and single dosing in healthy women. Contraception. 2013 Feb;87(2):193-200. doi: 10.1016/j.contraception.2012.07.001. Epub 2012 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	1.5 mg	Oral
Subject	Nomegestrol Acetate	Small molecule	2.5 mg	Oral

Indications

No indication recorded.