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https://hdl.handle.net/2440/107793
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Type: | Journal article |
Title: | 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 |
Author: | Wittert, G. Harrison, R. Buckley, M. Wlodarczyk, J. |
Citation: | Andrology, 2016; 4(1):41-45 |
Publisher: | Wiley-Blackwell |
Issue Date: | 2016 |
ISSN: | 2047-2919 2047-2927 |
Statement of Responsibility: | G. A. Wittert, R. W. Harris, M. J. Buckley and J. Wlodarczyk |
Abstract: | We compared a novel 5% testosterone (T) cream (AndroForte 5, Lawley Pharmaceuticals, Australia) with a 1% T gel (Testogel, Besins Healthcare, Australia). Using an open-label crossover design, subjects were randomized to one of two treatment sequences using either the T gel or T cream first in a 1 : 1 ratio. Each treatment period was 30 days with a 7-14 days washout period between them. On Days 1 and 30 of each treatment period blood was sampled at -15, -5 min, 0, 2, 4, 5, 6, 7, 8, 9, 10, 12 and 16 h post study drug administration. Sixteen men with established androgen deficiency aged between 29 and 73 years, who had undertaken a washout from prior testosterone therapy participated in the study. One subject failed to complete both arms and another was excluded post-completion because of a major protocol violation. Bioequivalence was established based on key pharmacokinetic (PK) variables: AUC, C(avg), C(max), T(max), % fluctuation (with and without baseline correction) for the two formulations of testosterone on Day 1 and Day 30. The ratio and 90% CI of AUC 0.99 (0.86-1.14), C(max) 1.02 (0.84-1.24) and C(avg) 0.99 (0.86-1.14) for T cream/T gel were within the predetermined bio-equivalence criteria of 80% to 125% at Day 30. There were no statistically significant differences between secondary biochemical markers: serum dihydrotestosterone (DHT), oestradiol (E2), sex hormone-binding globulin (SHBG), luteinizing hormone (LH) and (FSH). The two testosterone formulations were shown to be bioequivalent. |
Keywords: | Bioequivalence; male hypogonadism; pharmacokinetics; testosterone; transdermal testosterone |
Rights: | © 2016 American Society of Andrology and European Academy of Andrology |
DOI: | 10.1111/andr.12129 |
Published version: | http://dx.doi.org/10.1111/andr.12129 |
Appears in Collections: | Aurora harvest 8 Medicine publications |
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