Prospective Study of Topical Testosterone Gel (AndroGel) Versus Intramuscular Testosterone in Testosterone-Deficient HIV-Infected Men

Scott, James D. PharmD
Wolfe, Peter R. MD
Anderson, Peter MSN, NP
Cohan, Gary R. MD, FACP
Scarsella, Anthony MD

¹Western University of Health Sciences College of Pharmacy, Pomona, California, USA; ²David Geffen School of Medicine at UCLA, Los Angeles, California, USA; ³Private Practice, Beverly Hills, California, USA; ⁴Private Practice, Robertson Diagnostic Center, Beverly Hills, California, USA; ⁵Pacific Oaks Research, Pacific Oaks Medical Group, Beverly Hills, California, USA

Address for correspondence: James D. Scott, PharmD, Western University of Health Sciences College of Pharmacy, 309 E. Second Street, Pomona, CA 91766 USA. Email: [email protected]

HIV Clinical Trials 8(6):p 412-420, November-December 2007. | DOI: 10.1310/hct0806-412

Purpose:

Testosterone replacement therapy via deep intramuscular injections causes extraphysiologic variations in serum testosterone concentrations. A topical transdermal testosterone gel formulation (AndroGel®) 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.

Method:

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 peak-trough 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.

Conclusion:

Daily testosterone gel produced stable testosterone concentrations and improved quality of life compared with intermittent intramuscular testosterone injections.