Product Transference Study of Testagen™ TDS®-Testosterone
brief summary
This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has been applied and the potential of product to raise serum androgen levels in those women.
detailed description
48 Couples will be added to the protocol and a single dose applied by the male member of the couple. The female member of the couple will have undergone a baseline pharmacokinetic monitoring of her endogenous levels of Testosterone. At precise intervals by cohort on the day of the trial, the male will expose the skin onto which the trial materials were applied to the skin of his partner and she will then undergo another 24-hour multiple sample monitoring of her levels of testosterone.
official title
A Single-Dose, Single Period, Phase II Pharmacokinetic Study To Examine Testagen™ TDS®-Testosterone For Its Potential To Be Inadvertently Transferred By Skin Contact After Dosing In Healthy Adult Subjects