A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel
- Registration Number
- NCT04976595
- Lead Sponsor
- Acerus Pharmaceuticals Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 218
- 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).
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History of significant sensitivity or allergy to androgens, castor oil or product excipients.
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Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, an abnormal ECG.
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Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
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Body mass index (BMI) ≥ 35 kg/m^2.
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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
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History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
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History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration except for diabetes, or renal disease.
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History of stroke or myocardial infarction within the past 5 years.
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History of, or current or suspected, prostate or breast cancer.
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History of diagnosed, severe, untreated, obstructive sleep apnea.
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History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
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Currently using tobacco, e-cigarettes or other nicotine containing products.
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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.
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Receipt of any investigational product within 4 weeks of study start.
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Inability to understand and provide written informed consent for the study.
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Considered by the investigator or the sponsor-designated physician, for any reason, as an unsuitable candidate to receive Natesto.
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Participants working night-shifts.
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Participants performing strenuous manual labor while wearing the ABPM monitor.
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Participants with chronic atrial fibrillation (interferes with the ability to obtain precise ambulatory recordings).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Natesto 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 Change From Baseline in Hourly Average Systolic Blood Pressure (SBP) 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 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
Trial Locations
- Locations (30)
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
NYU Langone Health
🇺🇸New York, New York, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Tandem Clinical Research GI, LLC
🇺🇸Marrero, Louisiana, United States
Premier Urology Group
🇺🇸Edison, New Jersey, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Florida Healthcare Associates
🇺🇸Boynton Beach, Florida, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Urology of Indiana
🇺🇸Indianapolis, Indiana, United States
North Austin Urology
🇺🇸Austin, Texas, United States
Urology Center of Florida
🇺🇸Pompano Beach, Florida, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Prime Revival Research Institute
🇺🇸Flower Mound, Texas, United States
Investigative Clinical Research of Indiana
🇺🇸Elwood, Indiana, United States
The Research Foundation for the State University of New York at Buffalo
🇺🇸Williamsville, New York, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Crossroads Clinical Research
🇺🇸Victoria, Texas, United States
ProHEALTH Care Associates
🇺🇸Garden City, New York, United States
University of Miami
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
NanoHealth Associates
🇺🇸Miami Beach, Florida, United States
Coastal Bend Clinical Research
🇺🇸Corpus Christi, Texas, United States
Horizon Clinical Research Associates
🇺🇸Phoenix, Arizona, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Warren Alpert School of Medicine Brown University
🇺🇸Providence, Rhode Island, United States