Testosterone in Female Hypoactive Sexual Desire Disorder
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find
similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal
testosterone has been shown to improve sexual function in women after oophorectomy (Shifren
et al, Transdermal testosterone treatment in women with impaired sexual function after
oophorectomy, New England Journal of Medicine, 343; 682-8, 2000). In laboratory measures of
sexual arousal, a single application of transdermal testosterone enhanced vaginal blood and
increased erotic fantasy in normal volunteer women in the laboratory setting, four hours
after application (Tuiten et al, Can sublingual testosterone increase subjective and
physiological measures of laboratory-induced sexual arousal?, Arch Gen Psychiatry,
59;465,2002). We therefore planned a study of transdermal testosterone (25mg) marketed as
Androgel in female hypoactive sexual desire disorder. Patients are recruited from the
sexology clinics at Soroka Hospital and the Beersheva Mental Health Center. They are
randomized to Androgel or placebo and given 10 packets and instructed on application to the
abdomen and shoulders, four hours before planned intercourse. Patients unable to discuss
planned intercourse with their partner are offered psychosexual counseling and those still
unable after three sessions are excluded. After one month patients on active Androgel are
crossed over to placebo or vice versa. Patients self-rate sexual response after each
intercourse using the Brief Index of Sexual Functioning for Women, and Arizona Sexual
Experiences Scale (ASEX)-Female and are rated in interview at the end of each month of
treatment using the Sexual Function Questionnaire (SFQ-V1). Our prn technique avoids the
androgenizing side effects of continuous daily treatment.