Clinical trial NCT05484167: Natesto Testosterone Nasal Gel for Hypogonadal Men
Official title: Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Erectile Dysfunction
Sexual Dysfunction
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Acerus Pharmaceuticals Corporation
First posted: 2022-08-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The patient crosses over at 90 days
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Comparison of Sexual Function Scores Recorded at Baseline and End of Study
timeFrame: At Baseline and at the end of the study (Day 180)
measure: Comparison of Erection Success Recorded at Baseline and End of Study
timeFrame: At Baseline and at the end of the study (Day 180)
measure: Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study
timeFrame: At Baseline and at the end of the study (Day 180)
measure: Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study
timeFrame: Baseline and at the end of the study (Day 180)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, Division of Urology
state: Utah
Study officials:
affiliation: University of Utah, Division of Urology, Department of Surgery
name: James Hotaling, MS, MS
role: PRINCIPAL_INVESTIGATOR
References: