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
Autor: | Gary A. Wittert, M. J. Buckley, R. W. Harrison, J. Wlodarczyk |
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Rok vydání: | 2015 |
Předmět: |
Adult
Male medicine.medical_specialty Urology Endocrinology Diabetes and Metabolism 030232 urology & nephrology Skin Cream 1-Testosterone Bioequivalence Administration Cutaneous 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Endocrinology Sex hormone-binding globulin Internal medicine Sex Hormone-Binding Globulin Androgen deficiency medicine Humans Testosterone Aged 030219 obstetrics & reproductive medicine Cross-Over Studies biology Estradiol business.industry Hypogonadism Dihydrotestosterone Luteinizing Hormone Middle Aged medicine.disease Crossover study Reproductive Medicine chemistry Therapeutic Equivalency biology.protein Androgens Follicle Stimulating Hormone Luteinizing hormone business Gels medicine.drug |
Zdroj: | Andrology. 4(1) |
ISSN: | 2047-2927 |
Popis: | 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. |
Databáze: | OpenAIRE |
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