Transdermal Testosterone Gel for Low Libido

(TESTA MIND Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new skin-applied testosterone gel to determine its effectiveness for women experiencing low sexual desire, a common issue during menopause. The study compares the effects of the testosterone gel with a placebo (a treatment with no active ingredient) to ensure accurate results. Women who have experienced low interest in sex, low arousal, or related symptoms for at least six months and are in a stable relationship or have a sexually active opportunity might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance treatment options for menopausal women.

Will I have to stop taking my current medications?

If you are on systemic estrogen or local vaginal estrogen, you can continue as long as your dose has been stable for at least 8 weeks before starting the trial and you agree to keep it stable. However, if you are currently using androgen therapy, DHEA, or anabolic steroids, you must stop at least 8 weeks before joining the trial.

Is there any evidence suggesting that transdermal testosterone gel is likely to be safe for humans?

Research shows that a testosterone gel applied to the skin might help increase sexual desire in women with low libido. Studies have found that this treatment is usually well-tolerated. Although complete information about its long-term effects, especially concerning heart health and breast cancer, remains unavailable, short-term studies haven't identified major safety concerns. Several studies have noted the gel's effectiveness and short-term safety, making it a promising option for enhancing sexual interest. Overall, the gel appears safe in the short term, but more research is needed to fully understand its long-term effects.12345

Why do researchers think this study treatment might be promising?

Unlike other treatments for low libido, which often involve oral medications or injections, transdermal testosterone gel offers a unique delivery method by applying a gel directly to the skin. This method allows testosterone to be absorbed gradually, potentially reducing side effects and offering a more consistent release into the bloodstream. Researchers are excited about this treatment because it could provide a more convenient and comfortable option for patients who may not tolerate other forms of testosterone replacement well.

What evidence suggests that transdermal testosterone gel might be an effective treatment for low libido?

Research shows that testosterone gel applied to the skin can help women with low sexual desire. Studies have found that it boosts sexual desire and increases the number of satisfying sexual experiences. Women using the gel reported more sexual activity and orgasms, along with feeling less distressed. One study specifically found that a daily dose of testosterone improved sexual function and reduced distress in postmenopausal women. Participants in this trial will receive either the transdermal testosterone treatment or a placebo. These findings suggest that testosterone gel could be a promising option for those experiencing low libido.12345

Are You a Good Fit for This Trial?

This trial is for peri- and postmenopausal women with Female Sexual Interest/Arousal Disorder (FSIAD), which includes symptoms like low sex drive, reduced arousal, and fewer sexual thoughts. Participants must have been amenorrheic for at least 12 months and have menopause-level follicle-stimulating hormone.

Inclusion Criteria

I have been diagnosed with FSIAD according to DSM-5 criteria.
I rarely or never think about sex.
I have not had a menstrual period for at least 12 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transdermal testosterone gel or placebo for 12 weeks

12 weeks
4 visits (in-person) at 0, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transdermal Testosterone Gel

Trial Overview

The TESTA-MIND study is testing a transdermal testosterone gel against a placebo to see if it can improve libido in women who are experiencing decreased sexual desire after menopause. The study randomly assigns participants to receive either the testosterone or placebo gel without them knowing which one they're getting.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Transdermal testosterone treatmentActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Citations

Transdermal Testosterone: Female HSDD

Multiple studies have found that libido can be improved in patients with HSDD through administering estrogen and testosterone as a combination or even ...

Transdermal Testosterone (Off-Label) for Hypoactive ...

Clinical studies evaluating transdermal testosterone for the treatment of HSDD in postmenopausal women used doses of approximately 1/10th of the FDA approved ...

Efficacy and safety of transdermal testosterone in ...

The T group had significantly more satisfying sexual episodes, sexual activity, orgasms, desire, significant change in Personal Distress Scale score, ...

Transdermal Testosterone Gel for Female Sexual Interest ...

The TESTA-MIND study will evaluate the efficacy and safety of a standardized compounded transdermal testosterone gel in a randomized, double- ...

Testosterone for Low Libido in Postmenopausal Women ...

In conclusion, use of the patch delivering 300 μg of testosterone per day significantly improved sexual function and decreased distress in ...