Trial · NCT04456296
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
NCT04456296, Phase 4, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2025-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism. Trials, record NCT04456296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04456296
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
- NCT number
- NCT04456296
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 673 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
- Interventions
- Aveed Injectable Product, Fortesta, Testim
- First posted
- 2020-07-02
- Last updated
- 2025-03-14
- Results first posted
- 2025-03-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS) | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
| Secondary | Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
| Secondary | Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
| Secondary | Change From Baseline in 24-Hour Average Heart Rate to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
| Secondary | Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
| Secondary | Percentage of Participants Taking New Antihypertensive Medications | EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
| Secondary | Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications | EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS) | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-Hour Average Heart Rate to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS | Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Taking New Antihypertensive Medications | EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications | EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms | Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS) | AVEED® (Testosterone Undecanoate Injection) | 2.77 | 95% Confidence Interval 0.95 to 4.59 | millimeters of mercury (mmHg) | |
| Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS) | FORTESTA® (Testosterone Gel) | 2.78 | 95% Confidence Interval 0.86 to 4.69 | millimeters of mercury (mmHg) | |
| Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS) | TESTIM® (Testosterone Gel) | 2.15 | 95% Confidence Interval 0.28 to 4.03 | millimeters of mercury (mmHg) | |
| Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS | AVEED® (Testosterone Undecanoate Injection) | 2.13 | 95% Confidence Interval 0.89 to 3.37 | mmHg | |
| Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS | FORTESTA® (Testosterone Gel) | 1.78 | 95% Confidence Interval 0.47 to 3.08 | mmHg | |
| Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS | TESTIM® (Testosterone Gel) | 1.21 | 95% Confidence Interval -0.06 to 2.49 | mmHg | |
| Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS | AVEED® (Testosterone Undecanoate Injection) | 1.85 | 95% Confidence Interval 0.79 to 2.91 | mmHg | |
| Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS | FORTESTA® (Testosterone Gel) | 1.22 | 95% Confidence Interval 0.10 to 2.34 | mmHg | |
| Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS | TESTIM® (Testosterone Gel) | 0.81 | 95% Confidence Interval -0.28 to 1.91 | mmHg | |
| Change From Baseline in 24-Hour Average Heart Rate to EOS | AVEED® (Testosterone Undecanoate Injection) | 2.89 | 95% Confidence Interval 1.47 to 4.31 | beats per minute |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AVEED® (Testosterone Undecanoate Injection) | 224 | |
| Overall Study | STARTED | FORTESTA® (Testosterone Gel) | 224 | |
| Overall Study | STARTED | TESTIM® (Testosterone Gel) | 225 | |
| Overall Study | Safety Population | AVEED® (Testosterone Undecanoate Injection) | 222 | |
| Overall Study | Safety Population | FORTESTA® (Testosterone Gel) | 223 | |
| Overall Study | Safety Population | TESTIM® (Testosterone Gel) | 225 | |
| Overall Study | Intent-to-Treat (ITT) Population | AVEED® (Testosterone Undecanoate Injection) | 222 | |
| Overall Study | Intent-to-Treat (ITT) Population | FORTESTA® (Testosterone Gel) | 223 | |
| Overall Study | Intent-to-Treat (ITT) Population | TESTIM® (Testosterone Gel) | 225 | |
| Overall Study | Full Analysis Set | AVEED® (Testosterone Undecanoate Injection) | 140 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | AVEED® (Testosterone Undecanoate Injection) | 1 | 222 | |
| other | Headache | Nervous system disorders | FORTESTA® (Testosterone Gel) | 2 | 223 | |
| other | Headache | Nervous system disorders | TESTIM® (Testosterone Gel) | 3 | 225 | |
| other | Blood testosterone increased | Investigations | AVEED® (Testosterone Undecanoate Injection) | 0 | 222 | |
| other | Blood testosterone increased | Investigations | FORTESTA® (Testosterone Gel) | 2 | 223 | |
| other | Blood testosterone increased | Investigations | TESTIM® (Testosterone Gel) | 3 | 225 | |
| other | Hypertension | Vascular disorders | AVEED® (Testosterone Undecanoate Injection) | 7 | 222 | |
| other | Hypertension | Vascular disorders | FORTESTA® (Testosterone Gel) | 5 | 223 | |
| other | Hypertension | Vascular disorders | TESTIM® (Testosterone Gel) | 7 | 225 | |
| serious | Acute coronary syndrome | Cardiac disorders | AVEED® (Testosterone Undecanoate Injection) | 0 | 222 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AVEED® (Testosterone Undecanoate Injection) | 1 | 224 |
| Total, all-cause mortality | FORTESTA® (Testosterone Gel) | 0 | 224 |
| Total, all-cause mortality | TESTIM® (Testosterone Gel) | 0 | 225 |
| Total, other adverse events | AVEED® (Testosterone Undecanoate Injection) | 8 | 222 |
| Total, other adverse events | FORTESTA® (Testosterone Gel) | 9 | 223 |
| Total, other adverse events | TESTIM® (Testosterone Gel) | 13 | 225 |
| Total, serious adverse events | AVEED® (Testosterone Undecanoate Injection) | 3 | 222 |
| Total, serious adverse events | FORTESTA® (Testosterone Gel) | 1 | 223 |
| Total, serious adverse events | TESTIM® (Testosterone Gel) | 2 | 225 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04456296
GET https://conductscience.org/api/trials/v1/NCT04456296/results?page=2