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Natesto Testosterone Nasal Gel for Hypogonadal Men

Primary Purpose

Erectile Dysfunction, Sexual Dysfunction

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Natesto Nasal Product
Placebo
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Utah, Division of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Natesto

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2022
Last Updated
December 16, 2022
Sponsor
University of Utah
Collaborators
Acerus Pharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05484167
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
They study lost funding and decided to close the study down.
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Acerus Pharmaceuticals Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Sexual Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The patient crosses over at 90 days
Masking
ParticipantInvestigator
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natesto
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Natesto Nasal Product
Other Intervention Name(s)
Natesto Nasal Gel
Intervention Description
Nasal Gel used for 90 days then crossed over to placebo gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A nasal gel with no active ingredients
Primary Outcome Measure Information:
Title
Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.
Description
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.
Time Frame
At Baseline and at the end of the study (Day 180)
Secondary Outcome Measure Information:
Title
Comparison of Sexual Function Scores Recorded at Baseline and End of Study
Description
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.
Time Frame
At Baseline and at the end of the study (Day 180)
Title
Comparison of Erection Success Recorded at Baseline and End of Study
Description
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.
Time Frame
At Baseline and at the end of the study (Day 180)
Title
Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study
Description
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.
Time Frame
At Baseline and at the end of the study (Day 180)
Title
Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study
Description
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.
Time Frame
Baseline and at the end of the study (Day 180)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The study involves a diagnosis of Erectile Dysfunction. Therefore, all patients must have a penis, and this diagnosis.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hotaling, MS, MS
Organizational Affiliation
University of Utah, Division of Urology, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah, Division of Urology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Natesto Testosterone Nasal Gel for Hypogonadal Men

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