Clincosm LogoSign in Get a demo

A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel

Sponsor
Acerus Pharmaceuticals Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04976595
Collaborator
(none)
218
Enrollment
30
Locations
1
Arm
17
Anticipated Duration (Months)
7.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
218 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Natesto

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.

Drug: Natesto
Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
Other Names:
  • Testosterone Nasal Gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120 [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.

    Secondary Outcome Measures

    1. Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) [Baseline (Day 0) up to Day 120]

    2. Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) [Baseline (Day 0) up to Day 120]

    3. Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) [Baseline (Day 0) up to Day 120]

    4. Change From Baseline in 24-hour Average Pulse Pressure [Baseline (Day 0) up to Day 120]

    5. Change From Baseline in 24-hour Average Heart Rate [Baseline (Day 0) up to Day 120]

    6. Change From Baseline in Hourly Average Mean Arterial Pressure (MAP) [Baseline (Day 0) up to Day 120]

    7. Change From Baseline in Hourly Average Systolic Blood Pressure (SBP) [Baseline (Day 0) up to Day 120]

    8. Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP) [Baseline (Day 0) up to Day 120]

    9. Change From Baseline in Hourly Average Pulse Pressure [Baseline (Day 0) up to Day 120]

    10. Change From Baseline in Hourly Average Heart Rate [Baseline (Day 0) up to Day 120]

    11. Percentage of Participants With New Anti-hypertensive Medications [Baseline (Day 0) up to Day 120]

    12. Percentage of Participants With Dose Increases in Anti-hypertensive Medications [Baseline (Day 0) up to Day 120]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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).

    Exclusion Criteria:

    • 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

    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Clinical Therapeutics Birmingham Alabama United States 35235
    2 Horizon Clinical Research Associates Phoenix Arizona United States 85295
    3 Eclipse Clinical Research Tucson Arizona United States 85745
    4 Preferred Research Partners Little Rock Arkansas United States 72211
    5 Valley Clinical Trials Northridge California United States 91325
    6 Lynn Institute of the Rockies Colorado Springs Colorado United States 80918
    7 Excel Medical Clinical Trials Boca Raton Florida United States 33434
    8 Florida Healthcare Associates Boynton Beach Florida United States 33435
    9 NanoHealth Associates Miami Beach Florida United States 33140
    10 University of Miami Miami Florida United States 33146
    11 New Horizon Research Center Miami Florida United States 33165
    12 Urology Center of Florida Pompano Beach Florida United States 33060
    13 Precision Clinical Research Sunrise Florida United States 33351
    14 Investigative Clinical Research of Indiana Elwood Indiana United States 46036
    15 Urology of Indiana Indianapolis Indiana United States 46260
    16 Tandem Clinical Research GI, LLC Marrero Louisiana United States 70072
    17 Advanced Biomedical Research of America Las Vegas Nevada United States 89123
    18 Premier Urology Group Edison New Jersey United States 08837
    19 ProHEALTH Care Associates Garden City New York United States 11042
    20 AccuMed Research Associates Garden City New York United States 11530
    21 NYU Langone Health New York New York United States 10016
    22 The Research Foundation for the State University of New York at Buffalo Williamsville New York United States 14221
    23 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    24 Warren Alpert School of Medicine Brown University Providence Rhode Island United States 02903
    25 Coastal Carolina Research Center North Charleston South Carolina United States 29405
    26 North Austin Urology Austin Texas United States 78750
    27 Coastal Bend Clinical Research Corpus Christi Texas United States 78413
    28 Prime Revival Research Institute Flower Mound Texas United States 76201
    29 Baylor College of Medicine Houston Texas United States 77030
    30 Crossroads Clinical Research Victoria Texas United States 78413

    Sponsors and Collaborators

    • Acerus Pharmaceuticals Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acerus Pharmaceuticals Corporation
    ClinicalTrials.gov Identifier:
    NCT04976595
    Other Study ID Numbers:
    • NAT-2020-01
    First Posted:
    Jul 26, 2021
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Acerus Pharmaceuticals Corporation
    Hypogonadism
    Gonadal Disorders
    Testosterone
    Hormones
    Androgens
    Endocrine System Diseases
    Ambulatory Blood Pressure Monitoring
    Additional relevant MeSH terms:
    Hypogonadism
    Testosterone

    Study Results

    No Results Posted as of Jul 6, 2022