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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: Natesto

• Study Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. C. Sorli Chief Medical Officer; Phone Number: +1 289 326 5762; Email: csorli@aceruspharma.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Recruiting
      • Alabama Clinical Therapeutics
  • Arizona
    • Phoenix, Arizona, United States, 85295
      • Withdrawn
      • Horizon Clinical Research Associates
    • Tucson, Arizona, United States, 85745
      • Withdrawn
      • Eclipse Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Preferred Research Partners
  • California
    • Northridge, California, United States, 91325
      • Recruiting
      • Valley Clinical Trials
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Withdrawn
      • Lynn Institute Of The Rockies
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Recruiting
      • Excel Medical Clinical Trials
    • Boynton Beach, Florida, United States, 33435
      • Recruiting
      • Florida Healthcare Associates
    • Miami, Florida, United States, 33146
      • Recruiting
      • University of Miami
    • Miami, Florida, United States, 33165
      • Recruiting
      • New Horizon Research Center
    • Miami Beach, Florida, United States, 33140
      • Recruiting
      • NanoHealth Associates
    • Pompano Beach, Florida, United States, 33060
      • Recruiting
      • Urology Center Of Florida
    • Sunrise, Florida, United States, 33351
      • Recruiting
      • Precision Clinical Research
  • Indiana
    • Elwood, Indiana, United States, 46036
      • Recruiting
      • Investigative Clinical Research of Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Urology of Indiana
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Recruiting
      • Tandem Clinical Research GI, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Recruiting
      • Advanced Biomedical Research of America
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Recruiting
      • Premier Urology Group
  • New York
    • Garden City, New York, United States, 11530
      • Recruiting
      • AccuMed Research Associates
    • Garden City, New York, United States, 11042
      • Recruiting
      • ProHEALTH Care Associates
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • Williamsville, New York, United States, 14221
      • Recruiting
      • The Research Foundation for the State University of New York at Buffalo
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Withdrawn
      • Lynn Health Science Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Withdrawn
      • Warren Alpert School of Medicine Brown University
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Recruiting
      • Coastal Carolina Research Center
  • Texas
    • Austin, Texas, United States, 78750
      • Withdrawn
      • North Austin Urology
    • Corpus Christi, Texas, United States, 78413
      • Withdrawn
      • Coastal Bend Clinical Research
    • Flower Mound, Texas, United States, 76201
      • Recruiting
      • Prime Revival Research Institute
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
    • Victoria, Texas, United States, 78413
      • Recruiting
      • Crossroads Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0) and Day 120

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)	Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)	Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)	Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Pulse Pressure	Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Heart Rate	Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)	Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)	Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)	Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Pulse Pressure	Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Heart Rate	Baseline (Day 0) up to Day 120
Percentage of Participants With New Anti-hypertensive Medications	Baseline (Day 0) up to Day 120
Percentage of Participants With Dose Increases in Anti-hypertensive Medications	Baseline (Day 0) up to Day 120

Collaborators and Investigators

• Sponsor: Acerus Pharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (ACTUAL): July 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hypogonadism; Endocrine System Diseases; Testosterone; Androgens; Hormones; Ambulatory Blood Pressure Monitoring; Gonadal Disorders
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: NAT-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No