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Hormone Therapy
Natesto Testosterone Nasal Gel for Hypogonadal Men
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)
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 moreAwards & 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.
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
1,147 Previous Clinical Trials
1,699,621 Total Patients Enrolled
James Hotaling, MS, MSPrincipal InvestigatorUniversity of Utah, Division of Urology, Department of Surgery