Erectile DysfunctionPhase 4NCT05484167
Natesto Testosterone Nasal Gel for Hypogonadal Men
A Phase 4 study testing Natesto Nasal Product in people with Erectile Dysfunction and Sexual Dysfunction, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Sexual Dysfunction
- What is being tested?
- Natesto Nasal Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Division of Urology
Salt Lake City, Utah, 84132
About this study
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
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.
Read the 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.
- Conditions
- Erectile Dysfunction, Sexual Dysfunction
- Being tested
- Natesto Nasal Product, Placebo
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natesto Nasal ProductDrug
Also called Natesto Nasal Gel
Nasal Gel used for 90 days then crossed over to placebo gel
PlaceboDrug
A nasal gel with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At Baseline and at the end of the study (Day 180)
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.
Measured: At Baseline and at the end of the study (Day 180)
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.
Measured: 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
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.
Measured: Baseline and at the end of the study (Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Why it stopped: They study lost funding and decided to close the study down.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patient crosses over at 90 days
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Acerus Pharmaceuticals Corporation
- Responsible party
- Principal investigator, Jim Hotaling, University of Utah
- Investigators
- James Hotaling, MS, MS, Principal investigator, University of Utah, Division of Urology, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484167
- Sponsor's protocol ID
- 00144770
- Status last verified
- Dec 2022
- First submitted
- 9 Jun 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05484167
- Acronym / sponsor ID
- 00144770
- Conditions
- Erectile Dysfunction, Sexual Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: They study lost funding and decided to close the study down.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Acerus Pharmaceuticals Corporation
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The patient crosses over at 90 days
| Arm | Type | Receives |
|---|---|---|
| Natesto | Active comparator | Drug: Natesto Nasal ProductNatesto™ 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. |
| Placebo | Placebo comparator | Drug: PlaceboThis study involves a placebo. The placebo will look like the Natesto™ nasal pump and will contain a nasal gel, but without any active ingredients. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natesto Nasal ProductAlso: Natesto Nasal GelNasal Gel used for 90 days then crossed over to placebo gel | Drug | Natesto |
| PlaceboA nasal gel with no active ingredients | Drug | Placebo |
Primary outcome
Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.
Time frame: 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.
4 secondary outcomes
Comparison of Sexual Function Scores Recorded at Baseline and End of Study
Time frame: At Baseline and at the end of the study (Day 180)
Comparison of Erection Success Recorded at Baseline and End of Study
Time frame: At Baseline and at the end of the study (Day 180)
Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study
Time frame: 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
Time frame: Baseline and at the end of the study (Day 180)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hotaling, MS, MS principal investigator
University of Utah, Division of Urology, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natesto Nasal Product in people with Erectile Dysfunction and Sexual Dysfunction, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study. (time frame: At Baseline and at the end of the study (Day 180)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.