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
The University of Texas Health Science Center, Houston
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.
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 th…
Eligibility
- Age range
- 40–65 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria * 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 t…
Interventions
- OtherTransdermal 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.
- OtherTransdermal 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.
Location
- University of TexasHouston, Texas