Trial · NCT04320745
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
NCT04320745, Phase 4, Completed, Allergan; results first posted 2022-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants. Trials, record NCT04320745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04320745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
- NCT number
- NCT04320745
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 168 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Hypogonadism
- Interventions
- Androderm®
- First posted
- 2020-03-25
- Last updated
- 2022-07-12
- Results first posted
- 2022-07-12
Source ClinicalTrials.gov
Registered outcomes5
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 Blood Pressure (SBP) Obtained at Week 16 | Baseline and Week 16 | 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. |
| Secondary | Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16 | Baseline and Week 16 | 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. |
| Secondary | Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16 | Baseline and Week 16 | 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. |
| Secondary | Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16 | Baseline and Week 16 | 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. |
| Secondary | Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16 | Baseline and Week 16 | 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. |
Source ClinicalTrials.gov
Outcomes5
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 Blood Pressure (SBP) Obtained at Week 16 | Baseline and Week 16 | 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. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16 | Baseline and Week 16 | 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. | mmHg | MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16 | Baseline and Week 16 | 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. | mmHg | MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16 | Baseline and Week 16 | 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. | mmHg | MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16 | Baseline and Week 16 | 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. | beats per minute (bpm) | MEAN |
Source ClinicalTrials.gov
Results by group10
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 Blood Pressure (SBP) Obtained at Week 16 | Androderm® 4 mg | Baseline | 123.2 | Standard Deviation 11.86 | millimeters of mercury (mmHg) |
| Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16 | Androderm® 4 mg | Change from Baseline at Week 16 | 3.5 | Standard Deviation 8.93 | millimeters of mercury (mmHg) |
| Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16 | Androderm® 4 mg | Baseline | 74.4 | Standard Deviation 7.16 | mmHg |
| Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16 | Androderm® 4 mg | Change from Baseline at Week 16 | 1.2 | Standard Deviation 5.43 | mmHg |
| Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16 | Androderm® 4 mg | Baseline | 90.4 | Standard Deviation 7.65 | mmHg |
| Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16 | Androderm® 4 mg | Change from Baseline at Week 16 | 1.7 | Standard Deviation 6.12 | mmHg |
| Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16 | Androderm® 4 mg | Baseline | 48.8 | Standard Deviation 8.90 | mmHg |
| Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16 | Androderm® 4 mg | Change From Baseline at Week 16 | 2.3 | Standard Deviation 4.82 | mmHg |
| Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16 | Androderm® 4 mg | Baseline | 72.4 | Standard Deviation 9.92 | beats per minute (bpm) |
| Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16 | Androderm® 4 mg | Change From Baseline at Week 16 | 2.2 | Standard Deviation 6.16 | beats per minute (bpm) |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Androderm® 4 mg | 168 | |
| Overall Study | COMPLETED | Androderm® 4 mg | 121 | |
| Overall Study | NOT COMPLETED | Androderm® 4 mg | 47 |
Source ClinicalTrials.gov
Adverse events6
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 | APPLICATION SITE ERYTHEMA | General disorders | Androderm® 4 mg | 16 | 168 | 26 |
| other | APPLICATION SITE RASH | General disorders | Androderm® 4 mg | 13 | 168 | 14 |
| serious | BRADYCARDIA | Cardiac disorders | Androderm® 4 mg | 1 | 168 | 1 |
| serious | COVID-19 PNEUMONIA | Infections and infestations | Androderm® 4 mg | 1 | 168 | 1 |
| serious | FALL | Injury, poisoning and procedural complications | Androderm® 4 mg | 1 | 168 | 1 |
| serious | SYNCOPE | Nervous system disorders | Androderm® 4 mg | 1 | 168 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Androderm® 4 mg | 0 | 168 |
| Total, other adverse events | Androderm® 4 mg | 29 | 168 |
| Total, serious adverse events | Androderm® 4 mg | 2 | 168 |
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/NCT04320745
GET https://conductscience.org/api/trials/v1/NCT04320745/registered