NCT06794346

Sexual Effects of Transdermal or Vaginal Testosterone

Effects of Vaginal or Transdermal Testosterone on Sexual Response and Climacteric Symptoms in Postmenopausal Women

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 38 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.

Detailed description

-General To evaluate the therapeutic efficacy of testosterone treatment in sexual dysfunction in postmenopausal patients. -Specifics 1. To evaluate the prevalence of different sexual dysfunctions in postmenopausal patients, classifying them according to Diagnostic and Statistical Manual of Mental Disorders 5th (2013): * Female sexual desire / arousal disorder; * Female orgasm disorder; * pelvic or genital pain / penetration disorder; 2. To evaluate the response on climacteric symptoms after testosterone replacement using the Kupperman Menopausal Index;

Conditions

• Female Sexual Dysfunction
• Postmenopausal Symptoms
• Testosterone Deficiency
• Testosterone Adverse Reaction

Interventions

Type	Name	Description
DRUG	Transdermal testosterone	women will receive 300mcg of transdermal testosterone in cream daily for six months
DRUG	Vaginal testosterone gel	women will receive 300mcg of vaginal gel testosterone daily for six months
DEVICE	Placebo group	women will receive both vaginal gel and transdermal cream placebo for six months

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-10-01
• Completion: 2025-11-01
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: Brazil