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

Last updated: July 4, 2022
Sponsor: Acerus Pharmaceuticals Corporation
Overall Status: Active - Recruiting

Phase

4

Condition

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT04976595
NAT-2020-01
  • Ages 18-80
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntarily sign and date the study consent form(s) which have been approved by anInstitutional Review Board (IRB). Written consent must be obtained prior to theinitiation of any study procedures.
  • Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadismprior to age 65.
  • Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples obtained nogreater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout ofcurrent androgen replacement therapy if not testosterone naive. Historical values fromthe past 6 months may be used.
  • Testosterone Therapy naive, OR off any testosterone therapy for at least 4 months ORagree 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 4weeks.
  • Judged to be in good general health as determined by the principal investigator basedupon the results of a medical history, physical examination, vital signs, laboratoryprofile and a 12-lead electrocardiogram (ECG).

Exclusion

Exclusion Criteria:

  • History of significant sensitivity or allergy to androgens, castor oil or productexcipients.
  • Clinically significant findings in the pre-study examinations including abnormalbreast examination requiring follow-up, an abnormal ECG.
  • Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) orInternational 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 withdrawalseizures.
  • 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 investigatorwithin 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 nasalfracture within the previous 6 months or nasal fracture that caused a deviatedanterior 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, asan 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 obtainprecise ambulatory recordings).

Study Design

Total Participants: 218
Study Start date:
July 01, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Alabama Clinical Therapeutics

    Birmingham, Alabama 35235
    United States

    Active - Recruiting

  • Horizon Clinical Research Associates

    Phoenix, Arizona 85295
    United States

    Site Not Available

  • Eclipse Clinical Research

    Tucson, Arizona 85745
    United States

    Site Not Available

  • Preferred Research Partners

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Valley Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Excel Medical Clinical Trials

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Florida Healthcare Associates

    Boynton Beach, Florida 33435
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33146
    United States

    Active - Recruiting

  • NanoHealth Associates

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Urology Center of Florida

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Active - Recruiting

  • Investigative Clinical Research of Indiana

    Elwood, Indiana 46036
    United States

    Active - Recruiting

  • Urology of Indiana

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Advanced Biomedical Research of America

    Las Vegas, Nevada 89123
    United States

    Active - Recruiting

  • Premier Urology Group

    Edison, New Jersey 08837
    United States

    Active - Recruiting

  • AccuMed Research Associates

    Garden City, New York 11530
    United States

    Active - Recruiting

  • ProHEALTH Care Associates

    Garden City, New York 11042
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • The Research Foundation for the State University of New York at Buffalo

    Williamsville, New York 14221
    United States

    Active - Recruiting

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Warren Alpert School of Medicine Brown University

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • North Austin Urology

    Austin, Texas 78750
    United States

    Site Not Available

  • Coastal Bend Clinical Research

    Corpus Christi, Texas 78413
    United States

    Site Not Available

  • Prime Revival Research Institute

    Flower Mound, Texas 76201
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Crossroads Clinical Research

    Victoria, Texas 78413
    United States

    Active - Recruiting

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