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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07408440
Status
Not Yet Recruiting

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Conditions

  • Libido Disorder
  • Menopause
  • Sexual Dysfunction
  • Testosterone Deficiency

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

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 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transdermal testosterone treatment
    Transdermal gel testosterone treatment that will be provided by a clicker
  • Placebo Comparator: Placebo
    Transdermal gel placebo treatment that will be provided by a clicker

Primary Outcome Measure

The Female Sexual Function Index score [ Time Frame: On recruitment, and at 4,8, and 12 weeks of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of TexasHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Menopause
By specialty
Women's healthFertility
By research site
University of Texas· Houston, TX

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