Testagen™ Transference T1-09-13
A Single-Dose, Single Period, Phase II Pharmacokinetic Study To Examine TDS®-Testosterone For Its Potential To Be Inadvertently Transferred By Skin Contact After Dosing In Healthy Adult Subjects
Duration of Study in the UK
0 years, 4 months, 0 days
A new formulation of testosterone (Testagen™ TDS®-Testosterone) utilises the TDS® drug delivery system (Transdermal Delivery Solutions Corporation, Florida, USA) which is a novel, proprietary transdermal technology, developed for use in pharmaceutical, cosmetic and over-the-counter products.
Transdermal administration combines a rapid onset of action with a convenient and patient-friendly method of administration, which, it is believed, will provide an attractive alternative to the traditional gel route for the administration of Testosterone.
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.
London - West London & GTAC Research Ethics Committee
Date of REC Opinion
29 Feb 2016
Further Information Favourable Opinion