A Phase 4, multi-center, open-label, single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) study of Testosterone Cypionate Injection in Hypogonadal Men to assess change in 24-hour ambulatory blood pressure from Baseline to End of Treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Participants will receive Testosterone Cypionate Injection 200 mg/mL at established dose during the titration and treatment periods every two weeks (± 2 days) as a deep intramuscular injection in the gluteal muscle for 14-week study duration.
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Hillcrest Medical Research, LLC
DeLand, Florida, United States
Integrity Clinical Research Center, Inc.
Hialeah, Florida, United States
AccuMed Research Associates
Garden City, New York, United States
Number of participants with changes in 24-hour average systolic ambulatory blood pressure
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in 24-hour average diastolic ambulatory blood pressure
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in 24-hour average pulse pressure
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in 24-hour average heart rate
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Percent of participants taking new antihypertensive medications
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Percent of participants requiring increases in dose of antihypertensive medications from baseline
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average systolic blood pressure (SBP)
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average diastolic blood pressure (DBP)
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime mean arterial pressure (MAP)
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
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Aim Trials
Plano, Texas, United States
Alpine Clinical Organization Inc.
Clinton, Utah, United States
Number of participants with changes in daytime average pulse pressure
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average heart rate
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average systolic blood pressure (SBP)
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average diastolic blood pressure (DBP)
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time mean arterial pressure (MAP)
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average pulse pressure
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average heart rate
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with drug-related adverse events
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)