Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Me… (NCT07408440) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
United States150 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dis…
What they're measuring
1
The Female Sexual Function Index score
Timeframe: On recruitment, and at 4,8, and 12 weeks of treatment
Trial details
NCT IDNCT07408440
SponsorThe University of Texas Health Science Center, Houston