Natesto Testosterone Nasal Gel for Hypogonadal Men

NCT05484167 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 00144770
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.

  The primary endpoint of the study will be mean change in erectile function and satisfaction with sexual intercourse using the validated SHIM questionnaire. This questionnaire has been used extensively in clinical trials evaluating PDE5i for ED and is also used very commonly in the clinical practice. The SHIM Is a 5 item questionnaire that assesses the ability to get and maintain an erection sufficient for intercourse (Q1-Q4) and Q5 which assesses patient satisfaction. Each question is scored 0 to 5 with a total maximum score of 25. The investigators will look at the answers to all 5 questions and a higher score is interpreted as a better outcome.

  At Baseline and at the end of the study (Day 180)

Secondary Outcomes (4)

• Comparison of Sexual Function Scores Recorded at Baseline and End of Study

  At Baseline and at the end of the study (Day 180)

• Comparison of Erection Success Recorded at Baseline and End of Study

  At Baseline and at the end of the study (Day 180)

• Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study

  At Baseline and at the end of the study (Day 180)

• Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study

  Baseline and at the end of the study (Day 180)

Study Arms (2)

Natesto

ACTIVE COMPARATOR

Natesto™ is a testosterone nasal gel that is FDA approved to treat low testosterone. It delivers testosterone through the nasal passages and it is then absorbed into the blood stream. The nasal pump is placed at the opening of each nostril and then the participant would press down on the nasal pump to apply the gel. Each application takes about 10 seconds and the nasal pump applies a thin layer of gel that absorbs through the lining of the nose.

Drug: Natesto Nasal Product

Placebo

PLACEBO COMPARATOR

This study involves a placebo. The placebo will look like the Natesto™ nasal pump and will contain a nasal gel, but without any active ingredients.

Drug: Placebo

Interventions

Natesto Nasal Product DRUG

Nasal Gel used for 90 days then crossed over to placebo gel

Also known as: Natesto Nasal Gel

Natesto

Placebo DRUG

A nasal gel with no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: The study involves a diagnosis of Erectile Dysfunction. Therefore, all patients must have a penis, and this diagnosis.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Acerus Pharmaceuticals Corporation: collaborator

Study Sites (1)

University of Utah, Division of Urology

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• James Hotaling, MS, MS

  University of Utah, Division of Urology, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patient crosses over at 90 days

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: August 2, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)