A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)

Phase 4 Completed 24 enrolled Organon and Co

RandomizedParallel-groupOpen-labelBasic science

Summary

An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).

Timeline

Start: 2004-03
Primary completion: 2004-06
Completion: 2004-06

Publications

Results van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ethinyl estradiol	Small molecule	0.03 mg	Oral
Comparator	ethinyl estradiol	Small molecule	0.75 mg	Oral
Comparator	ethinyl estradiol	Small molecule	2.7 mg	Oral
Comparator	Etonogestrel	Unknown	11.7 mg	Other
Comparator	Levonorgestrel	Small molecule	0.15 mg	Oral
Comparator	norelgestromin	Unknown	6 mg	Topical

Indications

No indication recorded.