Trial Outcomes & Findings for A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants (NCT NCT04320745)
NCT ID: NCT04320745
Last Updated: 2022-07-12
Results Overview
SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
COMPLETED
PHASE4
168 participants
Baseline and Week 16
2022-07-12
Participant Flow
Participant milestones
| Measure |
Androderm® 4 mg
Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Overall Study
STARTED
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168
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Overall Study
COMPLETED
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121
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Overall Study
NOT COMPLETED
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47
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Reasons for withdrawal
| Measure |
Androderm® 4 mg
Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Overall Study
Adverse Event
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26
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Overall Study
Withdrawal by Subject
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4
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Overall Study
Lost to Follow-up
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12
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Overall Study
Protocol Deviation
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2
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Overall Study
Non-compliance With Study Drug
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2
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Overall Study
Reason Not Specified
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1
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Baseline Characteristics
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Baseline characteristics by cohort
| Measure |
Androderm® 4 mg
n=168 Participants
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Age, Continuous
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56.2 years
STANDARD_DEVIATION 11.52 • n=99 Participants
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Sex: Female, Male
Female
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0 Participants
n=99 Participants
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Sex: Female, Male
Male
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168 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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32 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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136 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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4 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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28 Participants
n=99 Participants
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Race (NIH/OMB)
White
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133 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline and Week 16Population: Modified Intent-to-treat (mITT) Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study.
SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Outcome measures
| Measure |
Androderm® 4 mg
n=62 Participants
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
Baseline
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123.2 millimeters of mercury (mmHg)
Standard Deviation 11.86
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Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
Change from Baseline at Week 16
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3.5 millimeters of mercury (mmHg)
Standard Deviation 8.93
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SECONDARY outcome
Timeframe: Baseline and Week 16Population: mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study.
DBP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Outcome measures
| Measure |
Androderm® 4 mg
n=62 Participants
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
Baseline
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74.4 mmHg
Standard Deviation 7.16
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Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
Change from Baseline at Week 16
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1.2 mmHg
Standard Deviation 5.43
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SECONDARY outcome
Timeframe: Baseline and Week 16Population: mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study.
MAP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Outcome measures
| Measure |
Androderm® 4 mg
n=62 Participants
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
Baseline
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90.4 mmHg
Standard Deviation 7.65
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Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
Change from Baseline at Week 16
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1.7 mmHg
Standard Deviation 6.12
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SECONDARY outcome
Timeframe: Baseline and Week 16Population: mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study.
Pulse pressure was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Outcome measures
| Measure |
Androderm® 4 mg
n=62 Participants
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
Baseline
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48.8 mmHg
Standard Deviation 8.90
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Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
Change From Baseline at Week 16
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2.3 mmHg
Standard Deviation 4.82
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SECONDARY outcome
Timeframe: Baseline and Week 16Population: mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study.
Heart rate was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Outcome measures
| Measure |
Androderm® 4 mg
n=62 Participants
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Baseline
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72.4 beats per minute (bpm)
Standard Deviation 9.92
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Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Change From Baseline at Week 16
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2.2 beats per minute (bpm)
Standard Deviation 6.16
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Adverse Events
Androderm® 4 mg
Serious adverse events
| Measure |
Androderm® 4 mg
n=168 participants at risk
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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Cardiac disorders
BRADYCARDIA
|
0.60%
1/168 • Number of events 1 • From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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Infections and infestations
COVID-19 PNEUMONIA
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0.60%
1/168 • Number of events 1 • From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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Injury, poisoning and procedural complications
FALL
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0.60%
1/168 • Number of events 1 • From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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Nervous system disorders
SYNCOPE
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0.60%
1/168 • Number of events 1 • From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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Other adverse events
| Measure |
Androderm® 4 mg
n=168 participants at risk
Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
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|---|---|
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General disorders
APPLICATION SITE ERYTHEMA
|
9.5%
16/168 • Number of events 26 • From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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General disorders
APPLICATION SITE RASH
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7.7%
13/168 • Number of events 14 • From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER