Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

Phase 2 Completed 350 enrolled Organon and Co Bayer · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.

Timeline

Start: 2003-10
Primary completion: 2006-12
Completion: 2006-12

Publications

Results Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Gronlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perheentupa A, Solomon A, Vaisala L, Wu FC, Zitzmann M. Male hormonal contraception: a double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2008 Jul;93(7):2572-80. doi: 10.1210/jc.2008-0265. Epub 2008 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Etonogestrel	Unknown	—	Subcutaneous
Comparator	Testosterone Undecanoate	Small molecule	750 mg	Intramuscular
Comparator	Testosterone Undecanoate	Small molecule	1000 mg	Intramuscular

Indications

No indication recorded.