RecruitingPhase 3ACTRN12625001376437

Testosterone for Low Sexual Desire in Premenopausal Women: A randomized, double-blind, placebo-controlled trial: The SYBIL study


Sponsor

Womens' Health Research Program, Monash University Public Health and Preventative Medicine

Enrollment

260 participants

Start Date

Jan 22, 2026

Study Type

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

Sex: FemalesMin Age: 35 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Low sexual desire is the most common sexual complaint among women, and it can cause real distress — affecting confidence, relationships, and overall quality of life. Testosterone, often thought of as a 'male' hormone, actually plays an important role in women's sexual desire too, and levels naturally decline from the mid-30s onward. This study is testing whether a daily testosterone cream (AndroFeme 1%) can safely restore sexual desire in premenopausal women aged 35–50 who are experiencing this problem. This is the first large, rigorous randomised controlled trial of testosterone for premenopausal women with low desire and associated personal distress. Half the participants will receive the testosterone cream, and half will receive an identical-looking placebo cream, over a treatment period. Neither participants nor their treating team will know which cream they are using until the study ends. You may be eligible if you are a premenopausal woman aged 35–50 with regular periods (or amenorrhoea due to progestogen contraception), are sexually active or want to be, and have noticed a significant and distressing decrease in your sexual desire compared to how you used to feel. Women currently using testosterone or other androgen therapies, or with serious medical conditions, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 app

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)

VIC, Australia

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ACTRN12625001376437