Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause (TESTA MIND)

February 12, 2026 updated by: Aya Mohr Sasson, The University of Texas Health Science Center, Houston

Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause - A Randomized, Double-blind, Placebo-controlled Trial for Improving Sexual Interest and Desire

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypoactive sexual desire disorder (HSDD) is the most prevalent form of female sexual dysfunction, particularly affecting peri- and postmenopausal women. Epidemiological studies estimate that between 8-14% of postmenopausal women experience clinically significant reductions in sexual desire that cause distress or interpersonal difficulty, significantly impacting quality of life and intimate relationships. In 2013, with the publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the diagnosis of HSDD was merged with female sexual arousal disorder under the category of Female Sexual Interest/Arousal Disorder (FSIAD). Despite this reclassification, clinical and pharmacological trials continue to use HSDD criteria, given their clearer operationalization and applicability in interventional studies.

Testosterone has long been recognized as a key modulator of female sexual desire and arousal. Observational studies show that circulating androgen levels decrease substantially with age and after menopause. Clinical trials of transdermal testosterone have demonstrated improvements in sexual function, specifically increased frequency of satisfying sexual events, enhanced desire, and reduced distress compared with placebo (7-9). Nevertheless, most clinical studies have utilized pharmaceutical-grade formulations not currently available in the United States, leading many clinicians to rely on compounded testosterone creams.

Currently, no FDA-approved testosterone therapy exists for women, and off-label use varies widely in formulation and administration. Transdermal preparations may provide a physiologic, steady release, and offer practical advantages over patches or systemic therapy, but robust randomized data remain scarce.

Evidence regarding compounded testosterone is limited and highlights concerns about variability in formulation, dosing accuracy, and absorption. Professional societies caution against the routine use of compounded hormones, citing the lack of FDA oversight, inconsistent bioavailability, and absence of long-term safety data. While compounded testosterone may represent a pragmatic solution in the absence of FDA-approved formulations, its use requires rigorous evaluation under standardized trial conditions to establish both efficacy and safety.

The TESTA-MIND study is designed to address this evidence gap by investigating the efficacy and safety of a standardized compounded testosterone gel in peri- and postmenopausal women with decreased libido. By conducting a randomized, double-blind, placebo-controlled trial, the investigators aim to provide high-quality data on the therapeutic role of testosterone in this underserved population, while addressing the clinical uncertainty and professional society concerns that currently limit its widespread adoption.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transdermal testosterone treatment
Transdermal gel testosterone treatment that will be provided by a clicker
Other: Transdermal testosterone gel
The compounded testosterone gel will be administered using a metered-dose delivery system calibrated to dispense 0.25 mL per actuation, corresponding to an estimated systemic exposure of approximately 300 µg of testosterone per day, within the physiologic range for females.
Placebo Comparator: Placebo
Transdermal gel placebo treatment that will be provided by a clicker
Other: Transdermal placebo gel
A testosterone-free compounded gel will be delivered via a metered-dose pump calibrated to dispense 0.25 mL per actuation. The placebo gel will use an identical metered-dose delivery system, packaging, and administration instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Female Sexual Function Index score
Time Frame: On 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.
On recruitment, and at 4,8, and 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient global impression of improvement
Time Frame: On recruitment, and at 4,8, and 12 weeks of treatment
This score uses a 7-point rating scale, ranging from 7=Very Much Improved to 1= Very Much Worse.
On recruitment, and at 4,8, and 12 weeks of treatment
Side effects of the treatment
Time Frame: On recruitment, and at 4,8, and 12 weeks of treatment
Including any of the following: acne, hirsutism, alopecia, voice change, clitoromegaly, and application-site reactions.
On recruitment, and at 4,8, and 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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