AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function.
Steidle C - J Clin Endocrinol Metab - 01-JUN-2003; 88(6): 2673-81
From NIH/NLM MEDLINE
NLM Citation ID:
12788872 (PubMed)
Comment:
- J Clin Endocrinol Metab. 2004 Dec;89(12):6358-9
PubMed ID: 15579803
Full Source Title:
Journal of Clinical Endocrinology and Metabolism
Publication Type:
Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
Language:
English
Author Affiliation:
Northeast Indiana Research, Fort Wayne, Indiana 46825, USA. chrisste@aol.com
Authors:
Steidle C; Schwartz S; Jacoby K; Sebree T; Smith T; Bachand R
North American AA2500 T Gel Study Group
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.
Major Subjects:
- Aging / * physiology
- Androgens / * blood
- Body Composition / * drug effects
- Sexual Behavior / * drug effects
- Testosterone / administration & dosage / adverse effects / pharmacokinetics / * therapeutic use
Additional Subjects:
- Administration, Cutaneous
- Affect / drug effects
- Aged
- Dihydrotestosterone / blood
- Double-Blind Method
- Drug Eruptions / epidemiology
- Gels
- Humans
- Incidence
- Lipids / blood
- Male
- Middle Aged
- Prostate-Specific Antigen / analysis
- Research Support, Non-U.S. Gov't
- Safety
Chemical Compound Name:
(Androgens); (Gels); (Lipids); 521-18-6(Dihydrotestosterone); 58-22-0(Testosterone); EC 3.4.21.77(Prostate-Specific Antigen)