A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel
NCT ID: NCT04976595
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
218 participants
INTERVENTIONAL
2021-07-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Natesto
Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
Interventions
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Natesto
Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
80 Years
MALE
No
Sponsors
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Acerus Pharmaceuticals Corporation
INDUSTRY
Responsible Party
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Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Horizon Clinical Research Associates
Phoenix, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Valley Clinical Trials
Northridge, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Florida Healthcare Associates
Boynton Beach, Florida, United States
University of Miami
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
NanoHealth Associates
Miami Beach, Florida, United States
Urology Center of Florida
Pompano Beach, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Investigative Clinical Research of Indiana
Elwood, Indiana, United States
Urology of Indiana
Indianapolis, Indiana, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Premier Urology Group
Edison, New Jersey, United States
ProHEALTH Care Associates
Garden City, New York, United States
AccuMed Research Associates
Garden City, New York, United States
NYU Langone Health
New York, New York, United States
The Research Foundation for the State University of New York at Buffalo
Williamsville, New York, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Warren Alpert School of Medicine Brown University
Providence, Rhode Island, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
North Austin Urology
Austin, Texas, United States
Coastal Bend Clinical Research
Corpus Christi, Texas, United States
Prime Revival Research Institute
Flower Mound, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Crossroads Clinical Research
Victoria, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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NAT-2020-01
Identifier Type: -
Identifier Source: org_study_id
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