Session: OR19-Female Reproductive Endocrinology
Room 102 (Moscone Center)
Objective: To determine the dose-dependent effects of graded doses of testosterone on sexual function in surgically menopausal women.
Methods: 71 surgically menopausal women received a standardized transdermal estradiol regimen during the 12-week run-in period, and were then randomized to receive weekly IM injections of placebo (n=15), or 3 (n=14), 6.25 (n=14), 12.5 (n=15) or 25 mg (n=13) testosterone enanthate for 24 weeks. Total and free testosterone levels were measured by LC-MS/MS and equilibrium dialysis, respectively. Sexual function was measured by the Brief Index of Sexual Functioning for Women (BISF-W) and a weekly Sexual Activity Log (SAL). Mood and well-being were assessed using the Psychological General Well-Being Index (PGWBI).
Results: 71 women were randomized. At baseline, mean age was 53 yrs, BMI 30 kg/m², total testosterone 13.7 ng/dl and free testosterone 2.2 pg/ml. On-treatment nadir testosterone concentrations were 14, 78, 105, 130 and 211 ng/dl at the 0, 3, 6.25, 12.5 and 25-mg doses, respectively. Changes in composite BISF-W scores, thoughts-desire, arousal, and frequency of sexual activity were significantly related to increases in free testosterone concentrations (p<0.05). The changes in sexual thoughts-desire and frequency of sexual activity were significantly greater in women assigned to the 25-mg group than in those assigned to placebo group (p< 0.01) but not at the lower dose groups. Sexual activity increased by 2.7 encounters per week in the 25-mg dose group and changes were significantly related to increases in free testosterone concentrations (p<0.01). PGWBI composite and vitality domain scores significantly increased at the 12.5mg and 25mg dose-group, respectively when compared to placebo (p<0.05). Frequency of androgenic adverse events was low.
Conclusion: Testosterone administration in surgically menopausal women for 24-weeks was associated with dose and concentration-dependent gains in several domains of sexual function. Clinically meaningful improvements were observed only at supraphysiologic testosterone doses and concentrations. Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects.
Nothing to Disclose: GH, SSB, TGT, MH, MD, NAM, RM, PEK, LEC, MU, EA, CD, HS, TWS, SB
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