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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Veröffentlicht in:International journal of impotence research 2015-03, Vol.27 (2), p.41-45
Hauptverfasser: Morgentaler, A, McGettigan, J, Xiang, Q, Danoff, T M, Gould, E M
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Sprache:eng
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Zusammenfassung: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