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Northeast Indiana Research (C.S.), Fort Wayne, Indiana 46825; Diabetes and Glandular Disease Research Associates (S.S.), San Antonio, Texas 78229; Integrity Medical Research (K.J.), Seattle, Washington 98133; and Auxilium Pharmaceuticals, Inc. (T.Se., T.Sm., R.B.), Norristown, Pennsylvania 19041
Address all correspondence and requests for reprints to: Christopher Steidle, M.D., Northeast Indiana Research, LLC, 2512 East DuPont Road, Suite 100, Fort Wayne, Indiana 46825. E-mail: chrisste{at}aol.com.
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.
This work was supported by Auxilium Pharmaceuticals, Inc.
The North American AA2500 T Gel Study Group includes: M. Bastuba (San Diego Urology, La Mesa, CA); W. Borkon (Park Nicollet Clinic, St. Louis Park, MN); M. Borofsky (Clinical Research Center of Reading, West Reading, PA); P. Butler (Coast Urology Medical Group, Inc., La Jolla, CA); J. Caldwell (Radiant Research, Inc., Gainesville, FL); C. Cascione (Gainesville VAMC, Gainesville, FL); C. Corder (COR Clinical Research, Oklahoma City, OK); Z. Dalu (Radiant Research, Inc., St. Louis, MO); T. Decker (Strafford Medical Association, Dover, NH); L. Galitz (South Florida Bioavailability Clinic, Miami, FL); E. Gillie (ICSL Clinical Studies, Fort Myers, FL); G. Gollapudi (Diabetes Center of the Southwest, Midland, TX); P. Hatcher (Volunteer Research Group, Knoxville, TN); K. Jacoby (Integrity Medical Research, Seattle, WA); M. Jayson (Medical & Clinical Research Associates, Bayshore, NY); W. Jones (Radiant Research, Inc., Boise, ID); L. Karsh (Western Urologic Research Center, Wheat Ridge, CO); J. Kaufman (Urology Research Options, Aurora, CO); W. Keating (SFM Clinical Trials, Scotland, PA); E. Killorin (Sandy Springs Urology, Atlanta, GA); T. Marbury (Orlando Clinical Research Center, Orlando, FL); J. McMurray (Medical Affiliated Research Center, Inc., Huntsville, AL); K. Meissner (Urology Consultants, San Antonio, TX); Y. Moy (The Connecticut Clinical Research Center/Urology Specialists, Waterbury, CT); T. Mulligan (McGuire VAMC Richmond, Richmond, VA); J. Newman (Quality Care Medical Center, Vista, CA); H. Offenberg (Radiant Research, Inc., Daytona Beach, FL); M. Parker (Radiant Research, Inc., Tucson, AZ); R. Pearson (Urology Center, Memphis, TN); T. Phillips (Metrolina Medical Research, Charlotte, NC); W. Pittman (Urology Centers of Alabama, Homewood, AL); R. Rollins (Southeastern Urological Center, Tallahassee, FL); G. Salazar (Sun Research Institute, San Antonio, TX); S. Schwartz (Diabetes and Glandular Disease Research Associates, San Antonio, TX); R. Sievers (Wells Institute for Health Awareness, Kettering, OH); F. Snoy (Urology Group of New Mexico, Albuquerque, NM); J. Soufer (Phoenix Internal Medicine Associates, Waterbury, CT); C. Steidle (Northeast Indiana Research, Fort Wayne, IN); E. Stulberger (Physicians in Urology, Livingston, NJ); J. Susset (MultiMed Research, Providence, RI); M. Vance (University of Virginia Health System, Charlottesville, VA); J. Walton (Radiant Research, Inc., Greer, SC); W. Wells, Jr. (Alabama Research Center, Birmingham, AL).
Abbreviations: AUC0–24, 0- to 24-h Area under the curve; BPH, benign prostatic hyperplasia; Cavg, mean concentration; Cmax, maximum concentration; Cmin, minimum concentration; DHT, dihydrotestosterone; DRE, digital rectal examination; %F, percentage fat; FM, fat mass; HDL, high-density lipoprotein; I-PSS, International Prostate Symptom Score; LBM, lean body mass; LDL, low-density lipoprotein; PK, pharmacokinetic; PSA, prostate-specific antigen; T, testosterone; TBM, total body mass; TC, total cholesterol.
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