Testagen™ Dose Ranging D1-09-13

• Research type

  Research Study

• Full title

  A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine Testagen™ TDS®-Testosterone 5% in Adult Male Subjects

• IRAS ID

  146877

• Contact name

  Arthur Tucker

• Contact email

  a.t.tucker@seahorsescientific.com

• Sponsor organisation

  Seahorse Scientific Services Ltd.

• Eudract number

  2013-001766-42

• 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 determine the blood levels achieved following increasing doses of Testagen™ TDS®-Testosterone.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  15/LO/2129

• Date of REC Opinion

  15 Feb 2016

• REC opinion

  Further Information Favourable Opinion