Natesto Testosterone Nasal Gel for Hypogonadal Men

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 atthe 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) orbreast 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)