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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

Study 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
1,094 Previous Clinical Trials
1,775,517 Total Patients Enrolled
James Hotaling, MS, MSPrincipal InvestigatorUniversity of Utah, Division of Urology, Department of Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include elderly individuals in its enrollment criteria?

"As outlined by the prerequisites for enrollment, potential participants must be between 18 and 64 years of age."

Answered by AI

Are there any available slots for individuals interested in participating in this research?

"According to the clinicaltrials.gov website, this medical trial is no longer seeking participants; it was initially posted on January 30th 2023 and last edited on November 5th 2022. However, there are 80 other studies currently recruiting patients right now."

Answered by AI

Is Natesto a reliable option with minimal risks?

"Natesto's safety rating is 3 on the Power scale thanks to its Phase 4 status, implying that this therapy has already been approved for use."

Answered by AI

What criteria must individuals meet in order to qualify for the clinical trial?

"To be considered for the trial, participants must demonstrate symptoms of erectile dysfunction and have ages between 18 to 64. The team is aiming to enroll 50 individuals in total."

Answered by AI

Who else is applying?

What state do they live in?
California
Utah
How old are they?
18 - 65
What site did they apply to?
University of Utah, Division of Urology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve tried mult meditation with unfavorable results . And I don’t want to have to inject my ***** every time I have ***. So I would love to be part of finding a new option for ppl like me by joining this trail.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Natesto Testosterone Nasal Gel for Hypogonadal Men
Jim Hotaling 2023. "Natesto Testosterone Nasal Gel for Hypogonadal Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05484167.
~0 spots leftby Apr 2025
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