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

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.

Inclusion Criteria * 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 Exclusion Criteria * 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 * Uncontrolled thyroid disease, significant liver disease, increased liver enzymes, or high cardiovascular risk judged unsafe by the primary care provider * Pregnancy, attempting conception, or breastfeeding * Dermatologic conditions preventing transdermal use; known hypersensitivity to the gel components