FDA Approval of Oral Testosterone Replacement Enabled by Phoenix NLME & Trial Simulator

Testosterone is a hormone that plays a key role in masculine growth and development during puberty. Hypogonadism is a clinical syndrome that results from failure of the testes to produce physiological levels of testosterone and a normal number of spermatozoa because of disruption of one or more levels of hypothalamic pituitary-testicular axis. Clarus Therapeutics developed and received FDA approval for an oral testosterone replacement product for treating men with certain forms of hypogonadism.