A new 2% testosterone gel formulation: a comparison with currently available topical preparations

Testosterone gel formulations have become a popular testosterone replacement therapy in patients with hypogonadism since their advent in the year 2000. The gel formulations restore testosterone levels to mid-normal physiological levels (14-17. 5 nmol/L) as early as within 24 h, and help alleviate the signs and symptoms of testosterone deficiency, thereby leading to an improved quality of life. Although testosterone gels have a favourable efficacy and safety profile as compared to injectable and patch formulations, risk of secondary exposure poses a challenge. Approved testosterone topical formulations include Tostrex®(Tostran®, Fortesta®), Androgel®(Testogel®), Testim®and Axiron®(solution), which have a favourable efficacy profile and positively impacted patient-reported outcome(s). Besides, Testavan, which is a 2% testosterone gel, is under registration in Europe and already approved in Australia in May 2017. Testavan uses a novel hydroalcoholic and highly viscous topical formulation. This product comes with a metered dose dispenser and a cap applicator that allows a hands-free application for precise dispensing and application. The present article provides a comprehensive review of pharmacokinetic, tolerability and safety profile of the testosterone gels available in the market along with the new 2% testosterone gel, Testavan.

Andrology. 2018 Mar 30 [Epub ahead of print]

S Arver, C Stief, J de la Rosette, T H Jones, A Neijber, D Carrara

Karolinska Institute, Stockholm, Sweden., Department of Urology, Ludwig-Maximilians-Universität München, München, Germany., AMC University Hospital, Amsterdam-Zuidoost, The Netherlands., Robert Hague Centre for Diabetes and Endocrinology, Barnsley and Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK., International Pharma Science Center, Ferring Pharmaceuticals, Copenhagen, Denmark., Ferring Galenisches Labor AG, Allschwil, Switzerland.