Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2023-01-01
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Natesto
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.
Natesto Nasal Product
Nasal Gel used for 90 days then crossed over to placebo gel
Placebo
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.
Placebo
A nasal gel with no active ingredients
Interventions
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Natesto Nasal Product
Nasal Gel used for 90 days then crossed over to placebo gel
Placebo
A nasal gel with no active ingredients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to read and complete electronic questionnaires in English.
* Adult males between the ages of 18-64 years
* Mild-moderate ED based on SHIM score between 8-21 at study entry
* Ability to take daily Tadalafil
* Ability to undergo venipuncture
* Ability to provide ejaculated semen sample
* Stable female sexual partner with sexual activity at least 1-3 times/month
* Hypogonadism defined as two (one done as SOC within the last 6 months and one done at the time of screening) early morning total testosterone lab values \<300
Exclusion Criteria
* History of Diabetes (HBA1c \>6.0)
* Hematocrit \< 35% or \> 54% at study entry
* Concurrent or Prior use of other exogenous testosterone or hormone therapy (SERM, aromatase inhibitor, gonadotropins) within the last 3 months.
* Concurrent use of other prescription medications for ED including PDE5 inhibitors, intracavernosal injection therapy, urethral suppositories
* Concurrent use of nitrates in any form
* History of pelvic radiation
* Spinal cord injury
* Any progressive neurologic disease (Alzheimer's, Parkinson's, multiple sclerosis, etc).
* History of penile prosthesis
* History of prostatectomy
* History of transurethral resection of prostate
* History of stroke or myocardial infarction within the past 6 months
* History of congestive heart failure
* History of untreated obstructive sleep apnea
* History of liver disease (Serum transaminases \> 2.5 times upper limit of normal)
* History of chronic kidney disease (GFR\<60 or Serum Cr \>2)
* History of, current or suspected, prostate (abnormal DRE or elevated PSA \>4.0) or breast cancer.
* History of azoospermia or oligospermia (\<15 million/ml)
* History of vasectomy
* History of Priapism
* History of Polycythemia Vera
* Receipt of any investigational product within 4 weeks of study enrollment
* Recurrent upper respiratory or sinus infection (\>3 times/month for \>6 months)
* Recurrent epistaxis (\>3 times/month for \>6 months)
18 Years
64 Years
MALE
Yes
Sponsors
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Acerus Pharmaceuticals Corporation
INDUSTRY
University of Utah
OTHER
Responsible Party
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Jim Hotaling
Principal Investigator
Principal Investigators
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James Hotaling, MS, MS
Role: PRINCIPAL_INVESTIGATOR
University of Utah, Division of Urology, Department of Surgery
Locations
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University of Utah, Division of Urology
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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00144770
Identifier Type: -
Identifier Source: org_study_id