HypogonadismPhase 4NCT04976595
A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel
A Phase 4 study testing Natesto in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 30 sites in United States.
Trial summary
The purpose of this study is to assess the change in 24-hour ambulatory blood pressure monitoring (ABPM) between baseline (Day 0) and Day 120 following 4 months of testosterone therapy with Natesto. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Natesto
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 30 sitesUnited States
- Study dates
- 1 Jul 2021to Dec 2022
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
- Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
- Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples obtained no greater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy if not testosterone naive. Historical values from the past 6 months may be used.
- Testosterone Therapy naive, OR off any testosterone therapy for at least 4 months OR agree to a 4-month washout of current testosterone therapy prior to entry at Visit 1.
- Average office blood pressure measurement <140 millimetre of mercury (mmHg) SBP -AND- <90 mmHg DBP.
- If the participant is on an antihypertensive regimen, he has been on it for at least 4 weeks.
- Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Who cannot join
- History of significant sensitivity or allergy to androgens, castor oil or product excipients.
- Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, an abnormal ECG.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
- Body mass index (BMI) ≥ 35 kg/m^2.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- Prostate specific antigen (PSA) > 4 ng/mL
Show all 24Show fewer
- Hematocrit < 35% or > 50%
- Baseline hemoglobin > 16 g/dL
- Hemoglobin A1C (HbA1C) > 9.0%
- Estimated glomerular filtration rate (eGFR) <45
- History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration except for diabetes, or renal disease.
- History of stroke or myocardial infarction within the past 5 years.
- History of, or current or suspected, prostate or breast cancer.
- History of diagnosed, severe, untreated, obstructive sleep apnea.
- History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
- Currently using tobacco, e-cigarettes or other nicotine containing products.
- History of nasal disorders such as nasal surgery; nasal trauma resulting in nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum; or sinus surgery or sinus disease.
- Receipt of any investigational product within 4 weeks of study start.
- Inability to understand and provide written informed consent for the study.
- Considered by the investigator or the sponsor-designated physician, for any reason, as an unsuitable candidate to receive Natesto.
- Participants working night-shifts.
- Participants performing strenuous manual labor while wearing the ABPM monitor.
- Participants with chronic atrial fibrillation (interferes with the ability to obtain precise ambulatory recordings).
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites, 23 recruiting
- Withdrawn
North Austin Urology
Austin, Texas, 78750
- Recruiting
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
- Recruiting
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
- Recruiting
Florida Healthcare Associates
Boynton Beach, Florida, 33435
- Withdrawn
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80918
- Withdrawn
Coastal Bend Clinical Research
Corpus Christi, Texas, 78413
- Recruiting
Premier Urology Group
Edison, New Jersey, 08837
- Recruiting
Investigative Clinical Research of Indiana
Elwood, Indiana, 46036
- Recruiting
Prime Revival Research Institute
Flower Mound, Texas, 76201
- Recruiting
ProHEALTH Care Associates
Garden City, New York, 11042
- Recruiting
AccuMed Research Associates
Garden City, New York, 11530
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
Urology of Indiana
Indianapolis, Indiana, 46260
- Recruiting
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
- Recruiting
Preferred Research Partners
Little Rock, Arkansas, 72211
- Recruiting
Tandem Clinical Research GI, LLC
Marrero, Louisiana, 70072
- Recruiting
University of Miami
Miami, Florida, 33146
- Recruiting
New Horizon Research Center
Miami, Florida, 33165
- Recruiting
NanoHealth Associates
Miami Beach, Florida, 33140
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
- Recruiting
Valley Clinical Trials
Northridge, California, 91325
- Withdrawn
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
- Withdrawn
Horizon Clinical Research Associates
Phoenix, Arizona, 85295
- Recruiting
Urology Center of Florida
Pompano Beach, Florida, 33060
- Withdrawn
Warren Alpert School of Medicine Brown University
Providence, Rhode Island, 02903
- Recruiting
Precision Clinical Research
Sunrise, Florida, 33351
- Withdrawn
Eclipse Clinical Research
Tucson, Arizona, 85745
- Recruiting
Crossroads Clinical Research
Victoria, Texas, 78413
- Recruiting
The Research Foundation for the State University of New York at Buffalo
Williamsville, New York, 14221
About this study
Official title: A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel
The purpose of this study is to assess the change in 24-hour ambulatory blood pressure monitoring (ABPM) between baseline (Day 0) and Day 120 following 4 months of testosterone therapy with Natesto.
- Conditions
- Hypogonadism
- Being tested
- Natesto
- Keywords
- Hypogonadism, Gonadal Disorders, Testosterone, Hormones, Androgens, Endocrine System Diseases, Ambulatory Blood Pressure Monitoring
- Medical subject headings
- Hypogonadism, Gonadal Disorders, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatestoDrug
Also called Testosterone Nasal Gel
Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Natesto | Experimental | Participants will administer Natesto, gel, intranasally, three times daily up to Day 120. A multiple-dose dispenser will be used for gel deposition into the nasal cavity. Receives: Drug: Natesto |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120
The change from baseline (Day 0) in 24-hour SBP after 120 days of Natesto treatment will be assessed.
Measured: Baseline (Day 0) and Day 120
Secondary outcomes (12)
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Pulse Pressure
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Heart Rate
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Pulse Pressure
Measured: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Heart Rate
Measured: Baseline (Day 0) up to Day 120
Percentage of Participants With New Anti-hypertensive Medications
Measured: Baseline (Day 0) up to Day 120
Percentage of Participants With Dose Increases in Anti-hypertensive Medications
Measured: Baseline (Day 0) up to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976595
- Sponsor's protocol ID
- NAT-2020-01
- Status last verified
- Jul 2022
- First submitted
- 16 Jul 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel
- ClinicalTrials.gov ID
- NCT04976595
- Acronym / sponsor ID
- NAT-2020-01
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism, Gonadal Disorders, Testosterone, Hormones, Androgens, Endocrine System Diseases, Ambulatory Blood Pressure Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Jul 2021 (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.
The purpose of this study is to assess the change in 24-hour ambulatory blood pressure monitoring (ABPM) between baseline (Day 0) and Day 120 following 4 months of testosterone therapy with Natesto.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natesto | Experimental | Drug: NatestoParticipants will administer Natesto, gel, intranasally, three times daily up to Day 120. A multiple-dose dispenser will be used for gel deposition into the nasal cavity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
- Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
- Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples obtained no greater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy if not testosterone naive. Historical values from the past 6 months may be used.
- Testosterone Therapy naive, OR off any testosterone therapy for at least 4 months OR agree to a 4-month washout of current testosterone therapy prior to entry at Visit 1.
- Average office blood pressure measurement <140 millimetre of mercury (mmHg) SBP -AND- <90 mmHg DBP.
Key exclusion criteria (24 listed)
- History of significant sensitivity or allergy to androgens, castor oil or product excipients.
- Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, an abnormal ECG.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
- Body mass index (BMI) ≥ 35 kg/m^2.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
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 |
|---|---|---|
| NatestoAlso: Testosterone Nasal GelNasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily. | Drug | Natesto |
Primary outcome
Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120
Time frame: Baseline (Day 0) and Day 120
The change from baseline (Day 0) in 24-hour SBP after 120 days of Natesto treatment will be assessed.
12 secondary outcomes
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Pulse Pressure
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Heart Rate
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Pulse Pressure
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Heart Rate
Time frame: Baseline (Day 0) up to Day 120
Percentage of Participants With New Anti-hypertensive Medications
Time frame: Baseline (Day 0) up to Day 120
Percentage of Participants With Dose Increases in Anti-hypertensive Medications
Time frame: Baseline (Day 0) up to Day 120
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Hypogonadism
RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
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.
30 sites 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 in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 30 sites 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 7 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. C. Sorli Chief Medical Officer (+1 289 326 5762, csorli@aceruspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120 (time frame: Baseline (Day 0) and Day 120). 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 6 Jul 2022.