MenopauseTESTA MINDNCT07408440
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
A study testing Transdermal testosterone gel in people with Menopause and Sexual Dysfunction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Sexual Dysfunction, Libido Disorder
- What is being tested?
- Transdermal testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Transdermal testosterone gel, Transdermal placebo gel
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal testosterone gelOther
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.
Transdermal placebo gelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal testosterone treatment | Active comparator | Transdermal gel testosterone treatment that will be provided by a clicker Receives: Other: Transdermal testosterone gel |
| Placebo | Placebo comparator | Transdermal gel placebo treatment that will be provided by a clicker Receives: Other: Transdermal placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Female Sexual Function Index score
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.
Measured: On recruitment, and at 4,8, and 12 weeks of treatment
Secondary outcomes (2)
Patient global impression of improvement
This score uses a 7-point rating scale, ranging from 7=Very Much Improved to 1= Very Much Worse.
Measured: On recruitment, and at 4,8, and 12 weeks of treatment
Side effects of the treatment
Including any of the following: acne, hirsutism, alopecia, voice change, clitoromegaly, and application-site reactions.
Measured: On recruitment, and at 4,8, and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohr Sasson, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408440
- Sponsor's protocol ID
- HSC-MS-26
- Acronym
- TESTA MIND
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Compounded Bioidentical Menopausal Hormone Therapy: ACOG Clinical Consensus No. 6. Obstet Gynecol. 2023 Nov 1;142(5):1266-1273. doi: 10.1097/AOG.0000000000005395.
PubMed 37856860Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O'Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12. doi: 10.1001/jama.291.14.1701.
PubMed 15082697Buster JE, Kingsberg SA, Aguirre O, Brown C, Breaux JG, Buch A, Rodenberg CA, Wekselman K, Casson P. Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial. Obstet Gynecol. 2005 May;105(5 Pt 1):944-52. doi: 10.1097/01.AOG.0000158103.27672.0d.
PubMed 15863529Davison SL, Bell R, Donath S, Montalto JG, Davis SR. Androgen levels in adult females: changes with age, menopause, and oophorectomy. J Clin Endocrinol Metab. 2005 Jul;90(7):3847-53. doi: 10.1210/jc.2005-0212. Epub 2005 Apr 12.
PubMed 15827095Meston CM, Freihart BK, Handy AB, Kilimnik CD, Rosen RC. Scoring and Interpretation of the FSFI: What can be Learned From 20 Years of use? J Sex Med. 2020 Jan;17(1):17-25. doi: 10.1016/j.jsxm.2019.10.007. Epub 2019 Nov 15.
PubMed 31735616Glynne S, Kamal A, Kamel AM, Reisel D, Newson L. Effect of transdermal testosterone therapy on mood and cognitive symptoms in peri- and postmenopausal women: a pilot study. Arch Womens Ment Health. 2025 Jun;28(3):541-550. doi: 10.1007/s00737-024-01513-6. Epub 2024 Sep 16.
PubMed 39283522Neijenhuijs KI, Hooghiemstra N, Holtmaat K, Aaronson NK, Groenvold M, Holzner B, Terwee CB, Cuijpers P, Verdonck-de Leeuw IM. The Female Sexual Function Index (FSFI)-A Systematic Review of Measurement Properties. J Sex Med. 2019 May;16(5):640-660. doi: 10.1016/j.jsxm.2019.03.001. Epub 2019 Apr 5.
PubMed 30956110