Could a testosterone gel reignite desire in menopausal women?
NCT ID NCT07408440
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a daily testosterone gel to see if it can safely improve sexual interest and arousal in women going through menopause. Researchers will compare the gel to a placebo in 150 women aged 40-65 who have been diagnosed with low sexual desire. The goal is to provide a much-needed treatment option for this common and distressing condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- testosterone gel
- What this could lead to
- If it works, this could offer a new, FDA-approved treatment option for low sexual desire in menopausal women.
- What could go wrong
- This trial has not started yet and is relatively small (150 women). The gel may cause side effects like acne or voice changes, and it may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- Does hormone therapy for menopause leave a mark on breasts and arteries?