Clinical trial NCT04976595: A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel
Official title: A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypogonadism
Keywords: Hypogonadism
Gonadal Disorders
Testosterone
Hormones
Androgens
Endocrine System Diseases
Ambulatory Blood Pressure Monitoring
Lead sponsor: Acerus Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 218
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120
timeFrame: Baseline (Day 0) and Day 120
Secondary outcomes:
measure: Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in 24-hour Average Pulse Pressure
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in 24-hour Average Heart Rate
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in Hourly Average Pulse Pressure
timeFrame: Baseline (Day 0) up to Day 120
measure: Change From Baseline in Hourly Average Heart Rate
timeFrame: Baseline (Day 0) up to Day 120
measure: Percentage of Participants With New Anti-hypertensive Medications
timeFrame: Baseline (Day 0) up to Day 120
measure: Percentage of Participants With Dose Increases in Anti-hypertensive Medications
timeFrame: Baseline (Day 0) up to Day 120
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Horizon Clinical Research Associates
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Boynton Beach
country: United States
facility: Florida Healthcare Associates
state: Florida
city: Miami Beach
country: United States
facility: NanoHealth Associates
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Pompano Beach
country: United States
facility: Urology Center of Florida
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Elwood
country: United States
facility: Investigative Clinical Research of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Urology of Indiana
state: Indiana
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group
state: New Jersey
city: Garden City
country: United States
facility: ProHEALTH Care Associates
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Williamsville
country: United States
facility: The Research Foundation for the State University of New York at Buffalo
state: New York
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Providence
country: United States
facility: Warren Alpert School of Medicine Brown University
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: North Austin Urology
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Clinical Research
state: Texas
city: Flower Mound
country: United States
facility: Prime Revival Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research
state: Texas
Study officials:
References: