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?

Hypoactive sexual desire disorder (HSDD) will be described as the most common form of female sexual dysfunction, particularly affecting peri- and postmenopausal women and associated with significant distress and reduced quality of life; although DSM-5 reclassified it under Female Sexual Interest/Arousal Disorder, HSDD criteria will continue to be used in clinical trials. 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.

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+