Pharmacokinetics and drying time of testosterone 2% gel in men with hypogonadism: a multicenter, open-label, single-arm trial

The objective of this study was to assess drying time after application of testosterone 2% gel (Fortesta Gel, Endo Pharmaceuticals), time needed for serum total testosterone (TT) to reach the eugonadal range (⩾300 ng dl –1 ), and time to steady-state serum TT. Thirty-four men with primary or seconda...

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Bibliographic Details
Published in:International journal of impotence research 2015-03, Vol.27 (2), p.41-45
Main Authors: Morgentaler, A, McGettigan, J, Xiang, Q, Danoff, T M, Gould, E M
Format: Article
Language:English
Subjects:
631/154/436/1729
692/699/2743/1526/1561
692/700/565/238
Adult
Aged
Androgens - administration & dosage
Androgens - blood
Androgens - pharmacokinetics
Care and treatment
Chemical properties
Clinical trials
Gels
Gels (Pharmacy)
Health aspects
Hormones
Humans
Hypogonadism
Hypogonadism - drug therapy
Male
Medicine
Medicine & Public Health
Mens health
Middle Aged
original-article
Pharmacokinetics
Pharmacology
Pharmacology, Experimental
Reproductive Medicine
Risk factors
rology
Sexual disorders
Testosterone
Testosterone - administration & dosage
Testosterone - blood
Testosterone - pharmacokinetics
Time Factors
Urology
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Summary:The objective of this study was to assess drying time after application of testosterone 2% gel (Fortesta Gel, Endo Pharmaceuticals), time needed for serum total testosterone (TT) to reach the eugonadal range (⩾300 ng dl –1 ), and time to steady-state serum TT. Thirty-four men with primary or secondary hypogonadism were enrolled in the study; 31 men were included in the pharmacokinetics (PKs) population. Testosterone 2% gel (40 mg) was applied once daily in the morning to the front and inner thighs for 14 days. Median gel drying time was 2.4 min (95% confidence interval (CI), 1.7–3.4 min; n =31). Serum TT concentrations reached the target eugonadal range with a median time of 2.9 h (95% CI, 1.9–4.3 h; n =24). Median time to steady-state serum TT concentration was 1.1 days (95% CI, 0.7–3.4 days; n =31). Six patients (17.6%; n =34) reported treatment-related adverse events; all were mild. The results from this 14-day PK study in men with hypogonadism suggest that testosterone 2% gel dries, on average, in
ISSN:0955-9930
1476-5489
DOI:10.1038/ijir.2014.28