Natesto Testosterone Nasal Gel for Hypogonadal Men

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 4

Conditions: Erectile Dysfunction; Sexual Dysfunction

Treatments: Drug: Placebo; Drug: Natesto Nasal Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05484167

00144770

Details and patient eligibility

About

To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

Full description

The purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to understand and provide written informed consent for the study.
• 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

• Morbid Obesity - BMI >35
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Natesto

Active Comparator group

Description:

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.

Treatment:

Drug: Natesto Nasal Product

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo