NCT05484167

Natesto Testosterone Nasal Gel for Hypogonadal Men

Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

Detailed description

The purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

Conditions

• Erectile Dysfunction
• Sexual Dysfunction

Interventions

Type	Name	Description
DRUG	Natesto Nasal Product	Nasal Gel used for 90 days then crossed over to placebo gel
DRUG	Placebo	A nasal gel with no active ingredients

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2025-04-01
• First posted: 2022-08-02
• Last updated: 2022-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study