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