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Hormone Therapy

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

Summary

This trial is testing whether using testosterone gel before sex can improve erectile function in men who have low testosterone levels and are using Tadalafil.

Eligible Conditions
  • Erectile Dysfunction
  • Sexual Dysfunction

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Acerus Pharmaceuticals CorporationIndustry Sponsor
13 Previous Clinical Trials
6,416 Total Patients Enrolled
University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,556 Total Patients Enrolled
James Hotaling, MS, MSPrincipal InvestigatorUniversity of Utah, Division of Urology, Department of Surgery
~0 spots leftby Jul 2025