Natesto Testosterone Nasal Gel for Hypogonadal Men

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT05484167

Collaborator

Acerus Pharmaceuticals Corporation (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Sexual Dysfunction	Drug: Natesto Nasal Product Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

The patient crosses over at 90 daysThe patient crosses over at 90 days

Masking:

Double (Participant, Investigator)

Masking Description:

Double-Blind

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Natesto 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 Nasal Gel used for 90 days then crossed over to placebo gel Other Names: Natesto Nasal Gel
Placebo Comparator: Placebo 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 A nasal gel with no active ingredients

Arm

Intervention/Treatment

Active Comparator: Natesto

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

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

Other Names:

Natesto Nasal Gel

Placebo Comparator: Placebo

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

A nasal gel with no active ingredients

Outcome Measures

Primary Outcome Measures

Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study. [At Baseline and at the end of the study (Day 180)]
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.

Secondary Outcome Measures

Comparison of Sexual Function Scores Recorded at Baseline and End of Study [At Baseline and at the end of the study (Day 180)]
Secondary outcomes will include a comparison of answers to question #2 in the Sexual Encounter Profile (SEP): Was the participant able to insert the penis into the partner's vagina? This is a question asked at baseline and at the end of the study. Answers are recorded as Yes or No and Yes is interpreted as a better outcome.
Comparison of Erection Success Recorded at Baseline and End of Study [At Baseline and at the end of the study (Day 180)]
Secondary outcomes will include a comparison of answers to question #3 in the Sexual Encounter Profile (SEP): Did the participant's erection last long enough to have successful intercourse? This is a question that will be asked at baseline and at the end of the study. Answers are recorded as Yes or No and Yes is interpreted as a better outcome.
Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study [At Baseline and at the end of the study (Day 180)]
Secondary outcomes will include a comparison of the total score for the Treatment Satisfaction Questionnaire for Medication (TSQM-9) at baseline and again at the end of the study. The TSQM-9 scale is descriptive in nature and includes the following scales such as: Very satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Very dissatisfied Higher scores are considered as a better outcome.
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)]
Secondary outcomes will include a comparison of the total score for the Change in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) at baseline and again at the end of the study. The EDITS scale is descriptive in nature and includes the following scales such as: Very satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Very dissatisfied Higher scores are considered as a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)