An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101-Reference-Cited by-同舟云学术

An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101

Published:2016-01 Issue:1 Volume:4 Page:41-45
ISSN:2047-2919
Container-title:Andrology
language:en
Short-container-title:Andrology

Author:

Wittert G. A.¹,Harrison R. W.²,Buckley M. J.³,Wlodarczyk J.⁴

Affiliation:

1. Adelaide University; Adelaide SA Australia

2. New England Research Institutes (NERI); Watertown MA USA

3. Lawley Pharmaceuticals; Perth WA Australia

4. JWCS; Sydney NSW Australia

Funder

Lawley Pharmaceuticals

Publisher

Wiley

Subject

Urology,Endocrinology,Reproductive Medicine,Endocrinology, Diabetes and Metabolism

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/andr.12129/fullpdf

Reference21 articles.

1. Testogel TGA approved Product Information 2014 https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2014-PI-02377-1

2. EMEA Guideline on the Investigation of bioequivalence http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

3. Comparative pharmacokinetics of testosterone esters

4. Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men;Dobs;J Clin Endocrinol Metab,1999

5. Transdermal testosterone delivery: testosterone patch and gel;Gooren;World J Urol,2003

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