Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause

Who can take part

• Women 40-65 years; peri- or postmenopausal - with one of the following:; 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); reduced or no interest in sex; few or no thoughts about sex; decreased sexual arousal or pleasure during sexual activity; reduced or no arousal in response to visual, written, or verbal cues; infrequent or no initiation of sexual activity within a relationship; reduced or no sensations in the genitals; They must also have:
• symptoms lasting 6 months or more
• significant distress about their symptoms
• symptoms that are not more accurately explained by a nonsexual mental health disorder, domestic abuse, medication, substance abuse, or another medical condition; In a stable relationship or sexually active opportunity (as defined by participant); If on systemic estrogen ± progestin or local vaginal estrogen: stable dose ≥8 weeks before randomization and agrees to remain stable; Able to consent and comply with study procedures

Who cannot take part

• Current or recent (≤8 weeks) androgen therapy, dehydroepiandrosterone (DHEA), or anabolic steroids
• 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
• Uncontrolled thyroid disease, significant liver disease, increased liver enzymes, or high cardiovascular risk judged unsafe by the primary care provider
• Dermatologic conditions preventing transdermal use; known hypersensitivity to the gel components
• Total T above premenopausal upper physiologic range at baseline (>55 ng/dL)
• Pregnancy, attempting conception, or breastfeeding