Not Yet RecruitingNot Applicable

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

United States150 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 dis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Female Sexual Function Index score

Timeframe: On recruitment, and at 4,8, and 12 weeks of treatment

Trial details

NCT IDNCT07408440

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-30

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