Prospective study of topical testosterone gel (AndroGel) versus intramuscular testosterone in testosterone-deficient HIV-infected men.
OBJECTIVE
Testosterone replacement therapy via deep intramuscular injections causes extraphysiologic variations in serum testosterone concentrations. A topical transdermal testosterone gel formulation (AndroGel(R)) provides sustained physiologic concentrations of serum testosterone. The objective of this open-label switch study was to compare pharmacokinetics, safety, tolerability, and efficacy of delivery of daily testosterone gel versus intramuscular testosterone injection every 1 or 2 weeks in hypogonadal human immunodeficiency virus (HIV)-infected men.


METHODS
Patients received intramuscular testosterone (100-200 mg/wk) for 8 weeks, then switched to daily topical testosterone gel (5-10 g gel/day) for 8 weeks. Study endpoints included free serum testosterone concentrations and quality-of-life scores.


RESULTS
Thirty patients (average age, 45 years) were recruited; 24 completed the study. Mean peak free testosterone concentrations with intramuscular testosterone and testosterone gel were 42 pg/mL and 23 pg/mL, respectively, and mean peaktrough fluctuations in free testosterone were 26.7 +/- 12.8 pg/mL and 2.7 +/- 10.7 pg/mL, respectively (p < .001). Quality-of-life scores indicated more improved physical and emotional well-being with gel versus intramuscular testosterone. No significant changes in laboratory parameters or lean body mass were noted.


CONCLUSIONS
Daily testosterone gel produced stable testosterone concentrations and improved quality of life compared with intermittent intramuscular testosterone injections.
Scott
James D
JD
Western University of Health Sciences College of Pharmacy, Pomona, California, USA. jdscott@western.edu
Wolfe
Peter R
PR
Anderson
Peter
P
Cohan
Gary R
GR
Scarsella
Anthony
A
D000287:Administration, Topical; D000328:Adult; D005782:Gels; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D044967:Serum / Q000737:chemistry; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000172:deficiency* / Q000493:pharmacokinetics
D005782:Gels; D013739:Testosterone