Hypoactive sexual desire disorder (HSDD) is described as the most common form of female sexual dysfunction, particularly affecting peri- and postmenopausal women and is associated with significant distress and reduced quality of life. The TESTA-MIND study will evaluate the efficacy and safety of a standardized compounded transdermal testosterone gel in a randomized, double-blind, placebo-controlled design to address the lack of FDA-approved options and limited high-quality evidence for treating decreased libido in women.
Staging by STRAW+10: stage (-2) or above
amenorrhea ≥12 mo
Follicle stimulating hormone in menopausal range
FSIAD diagnosis according to the DSM-5: (3/5 of the following symptoms)
Current or recent (≤8 weeks) androgen therapy, dehydroepiandrosterone (DHEA), or anabolic steroids
Total T above premenopausal upper physiologic range at baseline (>55 ng/dL)
History of hormone-dependent malignancy, untreated endometrial hyperplasia, or active gynecologic malignancy
Active severe psychiatric disorder (e.g., untreated major depression), substance use disorder, or relationship violence that precludes attribution of effect
Parallel
Transdermal testosterone gel
Other interventionThe compounded testosterone gel will be administered using a metered-dose delivery system calibrated to dispense 0.25 mL per actuation, corresponding to an estimated systemic exposure of approximately 300 µg of testosterone per day, within the physiologic range for females.
Transdermal placebo gel
Other interventionA testosterone-free compounded gel will be delivered via a metered-dose pump calibrated to dispense 0.25 mL per actuation. The placebo gel will use an identical metered-dose delivery system, packaging, and administration instructions.
The Female Sexual Function Index score
The Female Sexual Function Index (FSFI) is a widely used, 19-item self-report questionnaire assessing women's sexual health across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Responses are rated on scales (1-5), with higher scores indicating better function, and these are combined to form domain and total scores.
Patient global impression of improvement
This score uses a 7-point rating scale, ranging from 7=Very Much Improved to 1= Very Much Worse.
Side effects of the treatment
Including any of the following: acne, hirsutism, alopecia, voice change, clitoromegaly, and application-site reactions.
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