title: AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function.
abstract: Testosterone replacement in hypogonadal men improves body composition, mood, and sexual functioning. In this 90-d study, we compared the pharmacokinetics and treatment effectiveness of a topical testosterone gel (AA2500) at two concentrations, 50 mg/d and 100 mg/d, to a testosterone patch and placebo gel in 406 hypogonadal men. Pharmacokinetic profiles were obtained, body composition was measured, and mood and sexual function were monitored. AA2500 treatments resulted in dose-dependent improvements in all pharmacokinetic parameters, compared with testosterone patch and placebo. Mean average concentrations at d 90 T were 13.8, 17.1, 11.9, and 7.3 nmol/liter for 50 mg/d AA2500, 100 mg/d AA2500, testosterone patch, and placebo, respectively. At d 90, the 100 mg/d AA2500 treatment improved lean body mass by 1.7 kg and percentage of body fat by 1.2% to a significantly greater degree than either control treatment. Significant improvements in spontaneous erections, sexual desire, and sexual motivation were also evidenced with the 100 mg/d AA2500 dose in comparison with placebo. Testosterone gel was well tolerated; however, the testosterone patch resulted in a high rate of application site reactions. Overall, AA2500 is an effective, well tolerated treatment for hypogonadism.
authors.affiliation: Northeast Indiana Research, Fort Wayne, Indiana 46825, USA. chrisste@aol.com
authors.forename: C
authors.initials: C
authors.lastname: Steidle
authors.forename: S
authors.initials: S
authors.lastname: Schwartz
authors.forename: K
authors.initials: K
authors.lastname: Jacoby
authors.forename: T
authors.initials: T
authors.lastname: Sebree
authors.forename: T
authors.initials: T
authors.lastname: Smith
authors.forename: R
authors.initials: R
authors.lastname: Bachand
mesh_terms: D000279:Administration, Cutaneous; D000339:Affect / Q000187:drug effects; D000368:Aged; D000375:Aging / Q000502:physiology*; D000728:Androgens / Q000097:blood*; D001823:Body Composition / Q000187:drug effects*; D013196:Dihydrotestosterone / Q000097:blood; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000453:epidemiology; D005782:Gels; D006801:Humans; D015994:Incidence; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000032:analysis; D012449:Safety; D012725:Sexual Behavior / Q000187:drug effects*; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
chemical_list: D000728:Androgens; D005782:Gels; D008055:Lipids; D013196:Dihydrotestosterone; D013739:Testosterone; D017430:Prostate-Specific Antigen