Natesto for Erectile Dysfunction

Phase 4

Waitlist Available

Led By James Hotaling, MS, MS

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at the end of the study (day 180)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if a nasal gel with testosterone can help men with low testosterone and erectile dysfunction, who are already taking Tadalafil, by improving their erectile function and satisfaction when used before sex. Tadalafil is a medication for male erectile dysfunction (ED) that has been proven to improve erectile function.

Eligible Conditions

Erectile Dysfunction
Sexual Dysfunction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at the end of the study (day 180)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at the end of the study (day 180)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at the end of the study (day 180) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.

Secondary study objectives

Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study

Comparison of Erection Success Recorded at Baseline and End of Study

Comparison of Sexual Function Scores Recorded at Baseline and End of Study

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NatestoActive Control1 Intervention

Natesto™ is a testosterone nasal gel that is FDA approved to treat low testosterone. It delivers testosterone through the nasal passages and it is then absorbed into the blood stream. The nasal pump is placed at the opening of each nostril and then the participant would press down on the nasal pump to apply the gel. Each application takes about 10 seconds and the nasal pump applies a thin layer of gel that absorbs through the lining of the nose.

Group II: PlaceboPlacebo Group2 Interventions

This study involves a placebo. The placebo will look like the Natesto™ nasal pump and will contain a nasal gel, but without any active ingredients.

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