A Study to Evaluate Androderm's Effect on Blood Pressure in Adult Hypogonodal Male Participants.
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|ClinicalTrials.gov Identifier: NCT04320745|
Recruitment Status : Active, not recruiting
First Posted : March 25, 2020
Last Update Posted : June 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Androderm®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men|
|Actual Study Start Date :||May 19, 2020|
|Estimated Primary Completion Date :||June 24, 2021|
|Estimated Study Completion Date :||June 24, 2021|
All participants to receive standard dose of Androderm of 4 mg/day applied nightly on Visit 1. At Visit 2 testosterone concentration will be measured.
Nightly Transdermal dose of Androderm® of either 2 mg/day, 4 mg/day, or 6 mg/day.
- Change from baseline in 24-hour average systolic blood pressure (SBP) obtained at Week 16 [ Time Frame: At Week 16 ]
- Change from baseline in 24-hour average diastolic blood pressure (DBP) obtained at Week 16 [ Time Frame: At Week 16 ]
- Change from baseline in 24-hour average mean arterial pressure (MAP) obtained at Week 16 [ Time Frame: At Week 16 ]
- Change from baseline in 24-hour average pulse pressure obtained at Week 16 [ Time Frame: At Week 16 ]
- Change from baseline in 24-hour average heart rate obtained at Week 16 [ Time Frame: At Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320745
|Study Director:||Anna Chan||Allergan|