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

NCT07408440 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

OTHER

Transdermal testosterone 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.

OTHER

Transdermal placebo gel

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-03-30
Completion
2028-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408440 on ClinicalTrials.gov