title: Pharmacokinetics and drying time of testosterone 2% gel in men with hypogonadism: a multicenter, open-label, single-arm trial.
abstract: 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 <3 min after application and that testosterone 2% gel rapidly reaches the target eugonadal range and attains steady-state serum TT concentrations in about 1 day.
authors: Men's Health Boston, Brookline, MA, USA.
authors: A
authors: A
authors: Morgentaler
authors: Quality of Life Medical and Research Center, Tucson, AZ, USA.
authors: J
authors: J
authors: McGettigan
authors: Endo Pharmaceuticals, Malvern, PA, USA.
authors: Q
authors: Q
authors: Xiang
authors: Endo Pharmaceuticals, Malvern, PA, USA.
authors: T M
authors: TM
authors: Danoff
authors: Endo Pharmaceuticals, Malvern, PA, USA.
authors: E M
authors: EM
authors: Gould
mesh_terms: D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D005782:Gels; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D013997:Time Factors
chemical_list: D000728:Androgens; D005782:Gels; D013739:Testosterone