Testagen™ Transference T1-09-13

• Research type

  Research Study

• Full title

  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

• IRAS ID

  196406

• Contact name

  Arthur Tucker

• Contact email

  a.t.tucker@seahorsescientific.com

• Eudract number

  2013-001767-23

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  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.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  15/LO/2165

• Date of REC Opinion

  29 Feb 2016

• REC opinion

  Further Information Favourable Opinion