To determine dose-dependent effects of testosterone on sexual function, body composition, muscle performance, and physical function in hysterectomized women with and without oophorectomy.
71 menopausal women who previously underwent hysterectomy with or without oophorectomy with total testosterone<31ng/dl or free testosterone<3.5 pg/ml received a standardized transdermal estradiol regimen during the 12-week run-in period, and were then randomized to receive weekly IM injections of placebo, or 3, 6.25, 12.5 or 25 mg testosterone enanthate for 24 weeks. Total and free testosterone levels were measured by LC-MS/MS and equilibrium dialysis, respectively. The primary outcome was change in sexual function measured using Brief Index of Sexual Function (BISF-W); Secondary outcomes included changes in sexual activity, sexual distress, DeRogatis Inventory of Sexual Function, lean (LBM) and fat mass, muscle strength and power, and physical function.
71 women were randomized; five groups were similar at baseline. 62 women with analyzable data for the primary outcome were included in the final analysis. Mean on-treatment total testosterone concentrations were 19, 78, 102, 128 and 210ng/dl in the placebo, 3, 6.25, 12.5 and 25-mg groups, respectively. Changes in composite BISF-W scores, thoughts-desire, arousal, frequency of sexual activity, LBM, chest-press power and loaded stair-climb power were significantly related to increases in free testosterone concentrations; changes were significantly greater in women assigned to the 25-mg group when compared to placebo but not at the lower dose groups. Sexual activity increased by 2.7 encounters per week in 25-mg group. Frequency of androgenic adverse events was low.
Testosterone administration in hysterectomized women with and without oophorectomy for 24-weeks was associated with dose and concentration-dependent gains in several domains of sexual function, LBM, chest-press power and loaded stair-climb power. Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects.