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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Menopause, Sexual Dysfunction, Libido Disorder, Testosterone Deficiency

In brief

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.

Key facts

Study ID

NCT07408440

Run by

The University of Texas Health Science Center, Houston

People needed

150

Starts

2026-04-01

Expected to finish

2028-03-30

Last updated by the study team

2026-02-17

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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