10th Summit Meeting consensus: recommendations for regulatory approval for hormonal male contraception

Abstract

The investigators at the 6th Summit Meeting on Hormonal Male Contraception Petersberg Germany held on July 7-9 2002 recognized the need for standardized clinical trials to develop a hormonal male method and drafted several recommendations. At the 9th Summit Meeting on Hormonal Contraception Nyon Switzerland held on October 9-11 2005 the group of experts reviewed the status of clinical development projects for male hormonal contraception and discussed the need to update the recommendations. The following revised recommendations are the result of this discussion and present the consensus statement confirmed at the 10th Summit Meeting New York October 22-23 2006: It is stressed that the following recommendations are valid exclusively for hormonal methods for which the mechanism of action is based on the inhibition of sperm production. Methods with a different mode of action are outside the scope of these recommendations. The goal of hormonal male contraception is the reversible suppression of spermatogenesis to a level compatible with infertility. In principle this can be achieved by using an androgen alone or an androgen in combination with a gestagen or a GnRH antagonist. The success of this principle in terms of lowering sperm counts in semen to azoospermia or to severe oligozoospermia has been demonstrated in multiple studies. Some trials demonstrated the contraceptive efficacy of this approach when couples used no other method of contraception. Investigators agree that information gained from preliminary studies on male contraception have reached a stage that hormonal contraceptive products for men should now be proposed for development for general use. (excerpt)