Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder

This study is looking at a transdermal testosterone gel to help women experiencing Female Sexual Interest and Arousal Disorder (FSIAD), a condition where women have reduced or no interest in sex, few or no thoughts about sex, or decreased sexual arousal or pleasure. This often affects women during and after menopause. The study will compare the transdermal testosterone gel to a placebo gel (a gel without the active ingredient) to see if it can improve sexual function. You may be able to join if you are a woman between 40 and 65 years old, are in peri- or postmenopause, and have been diagnosed with FSIAD. The main way success will be measured is by changes in your Female Sexual Function Index score over 12 weeks. The current status of this study is unclear.

Study design: This study plans to enroll 150 women. It is designed as a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either the testosterone gel or the placebo gel, and neither you nor your doctor will know which you are receiving.
What's involved: Your Female Sexual Function Index score will be measured when you start the study, and again at 4, 8, and 12 weeks of treatment.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting

NAAges 40–65InterventionalTreatment

The University of Texas Health Science Center, Houston

~150 participants

Updated 2026-02-17 on ClinicalTrials.gov

What's tested:Transdermal testosterone gelTransdermal placebo gel

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

The Female Sexual Function Index score

Measured over On recruitment, and at 4,8, and 12 weeks of treatment

Conditions

Menopause

Sexual Dysfunction

Libido Disorder

Testosterone Deficiency

Where it's being run

1 sites across 1 states

Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

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

What this trial measures

The Female Sexual Function Index scoreOn recruitment, and at 4,8, and 12 weeks of treatment
The Female Sexual Function Index (FSFI) is a widely used, 19-item self-report questionnaire assessing women's sexual health across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Responses are rated on scales (1-5), with higher scores indicating better function, and these are combined to form domain and total scores.

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