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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
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.
Time frame: Baseline (Day 0) and Day 120
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Pulse Pressure
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in 24-hour Average Heart Rate
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Pulse Pressure
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
RECRUITINGHorizon Clinical Research Associates
Phoenix, Arizona, United States
WITHDRAWNEclipse Clinical Research
Tucson, Arizona, United States
WITHDRAWNPreferred Research Partners
Little Rock, Arkansas, United States
RECRUITINGValley Clinical Trials
Northridge, California, United States
RECRUITINGLynn Institute of the Rockies
Colorado Springs, Colorado, United States
WITHDRAWNExcel Medical Clinical Trials
Boca Raton, Florida, United States
RECRUITINGFlorida Healthcare Associates
Boynton Beach, Florida, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGNew Horizon Research Center
Miami, Florida, United States
RECRUITING...and 20 more locations
Time frame: Baseline (Day 0) up to Day 120
Change From Baseline in Hourly Average Heart Rate
Time frame: Baseline (Day 0) up to Day 120
Percentage of Participants With New Anti-hypertensive Medications
Time frame: Baseline (Day 0) up to Day 120
Percentage of Participants With Dose Increases in Anti-hypertensive Medications
Time frame: Baseline (Day 0) up to Day 120