Development of a transdermal gel for reversible male contraception.

While there are several easy-to-use reversible female contraceptives, little is available for men. Introduction of novel, cost-effective male contraceptives could have important downstream global health and economic benefits. Currently, nearly half of all pregnancies globally are unintended, with many resulting in unsafe abortions, a significant burden for women and families in many countries. Available reversible options for male contraception include male condoms or withdrawal, both with high typical use failure rates, and vasectomy, which is not easily reversible. Advanced methods of male hormonal contraception include combinations of progestin and androgen, generally testosterone itself. Administration of these steroids results in the suppression of gonadotropins leading to the suppression of sperm production with full reversibility within a few months. Importantly, the exogenous androgen replaces the suppressed endogenous testosterone, minimizing side effects for the user. Using the skin to deliver steroids in the systemic circulation is a well-accepted concept both for the treatment of hypogonadism and contraception. A transdermal gel delivering Nestorone (segesterone acetate) and testosterone is under development and is leading the way in advancing novel, self-delivered methods of male hormonal contraception.