An interventional study of Transdermal testosterone gel and Transdermal placebo gel in Menopause, Sexual Dysfunction and Libido Disorder, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
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.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women 40-65 years; peri- or - with one of the following:
FSIAD diagnosis according to the : (3/5 of the following symptoms)
They must also have:
symptoms that are not more accurately explained by a nonsexual mental health disorder, domestic abuse, medication, substance abuse, or another medical condition
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transdermal gel testosterone treatment that will be provided by a clicker
Other: Transdermal testosterone gel
Transdermal gel placebo treatment that will be provided by a clicker
Other: Transdermal placebo gel
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.
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.
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.
Time frame: On recruitment, and at 4,8, and 12 weeks of treatment
Patient global impression of improvement
This score uses a 7-point rating scale, ranging from 7=Very Much Improved to 1= Very Much Worse.
Time frame: 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.
Time frame: On recruitment, and at 4,8, and 12 weeks of treatment
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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