Natesto Testosterone Nasal Gel for Hypogonadal Men (NCT05484167) | Clinical Trial Compass
WithdrawnPhase 4
Natesto Testosterone Nasal Gel for Hypogonadal Men
Stopped: They study lost funding and decided to close the study down.
United States0Started 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Hist…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.
Timeframe: At Baseline and at the end of the study (Day 180)