Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause

NCT07408440 | Not Yet Recruiting

• 1 other identifier: HSC-MS-26
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Sexual Dysfunction; Libido Disorder; Testosterone Deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  On recruitment, and at 4,8, and 12 weeks of treatment

Secondary Outcomes (2)

• Patient global impression of improvement

  On recruitment, and at 4,8, and 12 weeks of treatment

• Side effects of the treatment

  On recruitment, and at 4,8, and 12 weeks of treatment

Study Arms (2)

Transdermal testosterone treatment

ACTIVE COMPARATOR

Transdermal gel testosterone treatment that will be provided by a clicker

Other: Transdermal testosterone gel

Placebo

PLACEBO COMPARATOR

Transdermal gel placebo treatment that will be provided by a clicker

Other: Transdermal placebo gel

Interventions

Transdermal testosterone gel OTHER

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 testosterone treatment

Transdermal placebo gel OTHER

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas

Houston, Texas, 77030, United States

Location

Related Publications (7)

• Compounded Bioidentical Menopausal Hormone Therapy: ACOG Clinical Consensus No. 6. Obstet Gynecol. 2023 Nov 1;142(5):1266-1273. doi: 10.1097/AOG.0000000000005395.

  PMID: 37856860 RESULT

• Anderson 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.

  PMID: 15082697 RESULT

• Buster 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.

  PMID: 15863529 RESULT

• Davison 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.

  PMID: 15827095 RESULT

• Meston 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.

  PMID: 31735616 RESULT

• Glynne 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.

  PMID: 39283522 RESULT

• Neijenhuijs 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.

  PMID: 30956110 RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)