Natesto Testosterone Nasal Gel for Hypogonadal Men

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: Acerus Pharmaceuticals Corporation
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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)