Clinical Trial: Testosterone in Female Hypoactive Sexual Desire Disorder
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Transdermal Testosterone Gel Prn Application for Hypoactive Sexual Desire Disorder in Women: A Controlled Study
Brief 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.
Detailed Summary:
The role of androgens in addition to estrogens in female sexual health has been known for several decades [Davis and Tran 2001]. Recently methods of delivering testosterone other than by injection have made the use of androgens in treatment more available. Testosterone gel is absorbed well [Wang, et al. 2000] and has been shown to be effective in the treatment of hypogonadal men. Doses of 100 mg gel rubbed into skin increased testosterone levels to 30-40 nmoles/L within 8-20 hours. Levels returned to baseline in this study within 1-2 days after cessation of chronic treatment although return to baseline after a single application was not studied.
A recent study [Shifren, et al. 2000] has shown that transdermal continuous patch testosterone dose 150micro g or 300micro g vs. placebo daily during the 12 week study improved sexual health including desire, arousal, and orgasm frequency in women with surgically induced menopause after oophorectomy. Blood levels reached 3.0nmoles/L (5x baseline). Shrifren et al [2000] found no significant side effects with transdermal sustained testosterone treatment. Another study [Goldstat, et al. 2003] looked at transdermal testosterone given in gel, 10mg a day given for 12 weeks in a double-blind design for 31 pre-menopausal women with a mean age of 40 years. The women entered the study presenting with low sexual desire. Testosterone treatment resulted in a significant improvement in psychological general well being and sexual self rating scale. No adverse effects were reported. Blood levels of testosterone increase about 2.5 times baseline to 2.6nmoles/L.
Despite the absence of side effects reported in the small studies for relatively short periods of time done up till now in women with testosterone treatment, in the treatment of a long term disorder such as diminished sexual desire it is rea
Sponsor: Beersheva Mental Health Center
Current Primary Outcome:
- Arizona Sexual Experiences Scale (ASEX)
- Sexual Function Questionnaire (SFQ-V1)
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Beersheva Mental Health Center
Dates:
Date Received: August 31, 2005
Date Started: April 2005
Date Completion: April 2006
Last Updated: November 23, 2009
Last Verified: November 2009
