Testosterone therapy for women with low androgen levels or body weight

Dr Dolan from the Massachusetts General Hospital, Boston, USA, presented findings from a double blind, placebo controlled study to evaluate the safety, efficacy and tolerability of testosterone administered to women with reduced androgen levels and low body weight.

A group of 57 HIV-positive women whose free testosterone was less than the median of the normal reference range, and whose weight was less than 90% of the ideal body weight (or whose weight loss was greater than 10%), were randomised to receive transdermal testosterone (4mg per patch) twice weekly (n=29) or placebo (n=28) for a period of six months.

The effect of the treatment was assessed in two ways: muscle mass was assessed by urinary creatinine excretion and muscle function was assessed by the Tufts Quantitative Muscle Function Test.

The investigators reported that at baseline all women had low weight (body mass index = 20.6+/-0.4 kg/m 2), significant weight loss from pre-illness maximum (18.7+/-1.2%), and reduced muscle function.

Among the women receiving the testosterone treatment there was significant rise in testosterone levels (total testosterone: 37+/-5 vs –2+/-2 ng/dL, p<0.0001; free testosterone: 3.7+/-0.5 vs -0.4+/-0.3 pg/mL, p<0.0001, testosterone and placebo arms respectively). The investigators observed that the testosterone was well tolerated, without adverse effects on immune function, lipids, glucose, liver function, body composition, or hirsuitism.

They also reported an increase in muscle mass (1.4+/-0.6 vs 0.3+/-0.8 kg, p=0.082). Muscle function in shoulders (0.4+/-0.3 vs -0.5+/-0.3 kg, p=0.023), elbows (0.3+/-0.4 vs -0.7+/-0.4 kg, p=0.036), knee extension (0.2+/-1.0 vs -1.7+/-1.3 kg, p=0.019) and knee flexion (0.7+/-0.5 vs 0.3+/-0.7 kg, p=0.036) increased in the women receiving testosterone compared to the women receiving placebo.

Dr Dolan concluded: “Testosterone administration is well-tolerated and increases muscle strength in low-weight HIV-infected women. Testosterone administration may be a useful adjunctive therapy to maintain muscle function in symptomatic HIV-infected women, but we need to find the optimal dosing strategy.”

Comment

In general, steroids should be combined with regular physical exercise to improve the lean weight gain. This may explain the non-significant difference in muscle mass.

Dolan S, Wilkie S, Aliabadi N et al. Effects of testosterone administration in HIV-infected women with low weight: A randomised, placebo-controlled study. 11th CROI 2004, Abstract 151.