Trial Outcomes & Findings for A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (NCT NCT04456296)
NCT ID: NCT04456296
Last Updated: 2025-03-14
Results Overview
The mean change from Baseline to EOS in 24-hour average systolic ambulatory blood pressure, for each treatment group was analyzed using an analysis of covariance (ANCOVA) model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average systolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
673 participants
Primary outcome timeframe
Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
AVEED® (Testosterone Undecanoate Injection)
Participants received 750 milligrams (mg)/3 milliliters (mL) of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Overall Study
STARTED
|
224
|
224
|
225
|
|
Overall Study
Safety Population
|
222
|
223
|
225
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
222
|
223
|
225
|
|
Overall Study
Full Analysis Set
|
140
|
133
|
134
|
|
Overall Study
COMPLETED
|
202
|
194
|
192
|
|
Overall Study
NOT COMPLETED
|
22
|
30
|
33
|
Reasons for withdrawal
| Measure |
AVEED® (Testosterone Undecanoate Injection)
Participants received 750 milligrams (mg)/3 milliliters (mL) of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
21
|
21
|
|
Overall Study
Adverse Event
|
2
|
2
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
6
|
|
Overall Study
Other than specified
|
0
|
1
|
4
|
|
Overall Study
Randomized, not treated
|
2
|
1
|
0
|
Baseline Characteristics
ITT Population included all randomized participants who received at least 1 dose/injection of study medication.
Baseline characteristics by cohort
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=222 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=223 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=225 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
Total
n=670 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 10.78 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 10.22 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 10.46 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
670 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
71 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
428 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
174 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
521 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
24-Hour Average Systolic Ambulatory Blood Pressure
|
124.90 mmHg
STANDARD_DEVIATION 12.178 • n=5 Participants • ITT Population included all randomized participants who received at least 1 dose/injection of study medication.
|
123.95 mmHg
STANDARD_DEVIATION 11.499 • n=7 Participants • ITT Population included all randomized participants who received at least 1 dose/injection of study medication.
|
124.45 mmHg
STANDARD_DEVIATION 12.505 • n=5 Participants • ITT Population included all randomized participants who received at least 1 dose/injection of study medication.
|
124.43 mmHg
STANDARD_DEVIATION 12.058 • n=4 Participants • ITT Population included all randomized participants who received at least 1 dose/injection of study medication.
|
PRIMARY outcome
Timeframe: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
The mean change from Baseline to EOS in 24-hour average systolic ambulatory blood pressure, for each treatment group was analyzed using an analysis of covariance (ANCOVA) model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average systolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS)
|
2.77 millimeters of mercury (mmHg)
Interval 0.95 to 4.59
|
2.78 millimeters of mercury (mmHg)
Interval 0.86 to 4.69
|
2.15 millimeters of mercury (mmHg)
Interval 0.28 to 4.03
|
SECONDARY outcome
Timeframe: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
The mean change from Baseline to EOS in 24-hour MAP, for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour MAP as covariate.EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS
|
2.13 mmHg
Interval 0.89 to 3.37
|
1.78 mmHg
Interval 0.47 to 3.08
|
1.21 mmHg
Interval -0.06 to 2.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
The mean change from Baseline to EOS in 24-hour average diastolic ambulatory blood pressure, for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average diastolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS
|
1.85 mmHg
Interval 0.79 to 2.91
|
1.22 mmHg
Interval 0.1 to 2.34
|
0.81 mmHg
Interval -0.28 to 1.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
The mean change from Baseline to EOS in 24-hour average heart rate, for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average heart rate as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Change From Baseline in 24-Hour Average Heart Rate to EOS
|
2.89 beats per minute
Interval 1.47 to 4.31
|
1.56 beats per minute
Interval 0.07 to 3.06
|
1.84 beats per minute
Interval 0.37 to 3.31
|
SECONDARY outcome
Timeframe: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
The mean change from Baseline to EOS in 24-hour average PP for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average PP as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS
|
0.80 mmHg
Interval -0.41 to 2.0
|
1.49 mmHg
Interval 0.22 to 2.75
|
1.40 mmHg
Interval 0.16 to 2.63
|
SECONDARY outcome
Timeframe: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
A new antihypertensive medication was any antihypertensive medication taken on or after the screening Visit through the EOS visit and not taken prior to the screening visit.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Percentage of Participants Taking New Antihypertensive Medications
|
1.4 Percentage of participants
|
1.5 Percentage of participants
|
2.2 Percentage of participants
|
SECONDARY outcome
Timeframe: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim ArmsPopulation: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.
A new antihypertensive medication was any antihypertensive medication taken on or after the screening Visit through the EOS visit and not taken prior to the screening visit.
Outcome measures
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=140 Participants
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=133 Participants
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=134 Participants
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
AVEED® (Testosterone Undecanoate Injection)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
FORTESTA® (Testosterone Gel)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
TESTIM® (Testosterone Gel)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=222 participants at risk
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=223 participants at risk
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=225 participants at risk
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.44%
1/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.45%
1/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
1/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.44%
1/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.44%
1/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.45%
1/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.45%
1/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.00%
0/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
Other adverse events
| Measure |
AVEED® (Testosterone Undecanoate Injection)
n=222 participants at risk
Participants received 750 mg/3 mL of injection administered by intramuscular route on Days 2, 30 and 100.
|
FORTESTA® (Testosterone Gel)
n=223 participants at risk
Participants received 40 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
TESTIM® (Testosterone Gel)
n=225 participants at risk
Participants received 50 mg once daily topical gel application starting from Day 2. Participants were followed up on Day 16, Day 37, Day 67, and Day 97.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.45%
1/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.90%
2/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
1.3%
3/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Investigations
Blood testosterone increased
|
0.00%
0/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
0.90%
2/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
1.3%
3/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
3.2%
7/222 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
2.2%
5/223 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
3.1%
7/225 • Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
All cause-mortality was based on enrolled participants. SAEs and other non-serious AEs were based on the Safety population that included all participants who received at least 1 dose of study drug. Three participants did not receive at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place