Natesto Testosterone Nasal Gel for Hypogonadal Men

NCT05484167 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • James Hotaling, MS, MS · University of Utah, Division of Urology, Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-01-01
Completion
2025-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT05484167 on ClinicalTrials.gov