Natesto Testosterone Nasal Gel for Hypogonadal Men

Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor

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.

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.

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)