Effects of long-term testosterone administration in HIV-infected women: a randomized, placebo-controlled trial

Abstract

Objective: Androgen deficiency is common in HIV-infected women. We investigated the long-term effects of transdermal testosterone on body composition, bone mineral density, quality of life, and safety.

Design: Twenty-five HIV-infected women with free testosterone below the median (< or =3 pg/ml) of the female normal range were randomized to receive transdermal testosterone (300 microg twice weekly) or identical placebo over 18 months.

Results: Women demonstrated low androgen levels (1.3 +/- 0.1 pg/ml) with relatively low weight (22.8 +/- 0.6 kg/m) and low bone mineral density (-0.61 +/- 0.17 SD hip T score) at baseline. No statistically significant differences were seen between the groups at baseline. The discontinuation rate was 16% and did not differ between treatment groups (P = 0.24). Free testosterone by equilibrium dialysis increased over 18 months (7.9 +/- 1.8 vs. 0.3 +/- 0.4 pg/ml; P = 0.002, testosterone vs. placebo). Testosterone was well tolerated and did not affect lipids, liver, or safety indices. Lean mass (1.8 +/- 0.5 vs. 0.8 +/- 0.9 kg; P = 0.04) and BMI (1.6 +/- 0.4 vs. 0.8 +/- 0.6 kg/m; P = 0.03, testosterone vs. placebo) increased in response to testosterone, whereas fat mass remained unchanged. Testosterone increased bone mineral density at the hip (0.01 +/- 0.01 vs. -0.01 +/- 0.01 g/cm; P = 0.02) and trochanter (0.01 +/- 0.01 vs. -0.02 +/- 0.01 g/cm; P = 0.01, testosterone vs. placebo). Testosterone significantly improved depression indices (-6.8 +/- 2.2 vs. -1.9 +/- 3.1; P = 0.02) and problems affecting sexual function (-1.8 +/- 0.8 vs. 0.5 +/- 0.5; P = 0.01, testosterone vs. placebo).

Conclusion: Long-term testosterone administration was well tolerated in HIV-infected women and resulted in significant improvements in body composition, bone mineral density, and quality of life indices. Further evaluation of the safety and efficacy of testosterone use among HIV-infected women is warranted.

Figures

Figure 1

Schematic overview of study enrollment

Figure 2

Individual responses for variables from baseline to 9 months and baseline to 18 months. Individual responses for key variables represent change after 9 months (Panel A) and after 18 months (Panel B). Treatment responses above the 0 line indicate positive responders. The overall P values by longitudinal linear effects modeling include: Total hip (P = 0.02); BMI (P = 0.03); Lean mass (P = 0.04); and Fat mass (P = 0.16).