Testosterone for Low Sexual Desire in Premenopausal Women: A randomized, double-blind, placebo-controlled trial: The SYBIL study
Womens' Health Research Program, Monash University Public Health and Preventative Medicine
260 participants
Jan 22, 2026
Interventional
Conditions
Summary
Low sexual desire with associated distress is the most common sexual dysfunction in women, with a prevalence in Australian premenopausal women in the order of 8%. Testosterone has been shown to be an effective treatment of low sexual desire with associated personal distress in postmenopausal women. However, while small studies suggest a potential benefit of testosterone for premenopausal women aged 35 to 45 years with low desire, the available data is insufficient to support its use in premenopausal women. Specifically, improvement in sexual desire, arousal and satisfaction with AndroFeme1® 10mg/day, was seen in a double-blind, placebo controlled pilot study of 34 women aged 35 to 45 years. Sexually-related personal distress was not evaluated in this study. In a separate study, another transdermal skin spray preparation improved the frequency of satisfying sexual events in premenopausal women compared with placebo, sexual desire did not improve and associated distress was not evaluated. However, testosterone blood levels in premenopausal women decline by about 25% between the ages of 18 to 39 years and continue to decline with age, but with little, or no change over the menopause transition. Therefore whether testosterone therapy is effective for the treatment of low sexual desire and associated personal distress in premenopausal women aged 35 to 50 years warrants investigation.
Eligibility
Plain Language Summary
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Interventions
Active treatment contains 1% testosterone in a 50ml metered dose pump-pack. It is a transdermal cream delivering 0.25ml per pump (2,5mg dose of testosterone). The participant will be instructed to apply 2 or 4 pumps, equivalent to 5mg-10mg of testosterone, to the upper outer thigh or buttock daily for 6 months. The starting dose at Week 0 is 5mg of testosterone. It can be increased up to 10mg of testosterone if the participant reports no improvement in the sexual desire at week 12. Compliance will be assessed by collection and weighing of returned cream containers at week 12 and week 26 after commencement of treatment.
Locations(1)
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ACTRN12625001376437