Trial · NCT04274894
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
NCT04274894, Phase 4, Completed, AbbVie; results first posted 2022-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism. Trials, record NCT04274894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04274894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
- NCT number
- NCT04274894
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 246 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Hypogonadism
- Interventions
- AndroGel 1.62%
- First posted
- 2020-02-18
- Last updated
- 2022-12-15
- Results first posted
- 2022-12-15
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP) | Baseline, Week 16 | Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP) | Baseline, Week 16 | Per protocol set analysis: all participants who received at least 1 dose of study drug, were at least 85% compliant to study drug, and had valid Baseline and end of treatment systolic ABPM data | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP) | AndroGel 1.62% | 1.9 | Standard Deviation 8.99 | mmHg |
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 | AndroGel 1.62% | 246 | |
| Overall Study | COMPLETED | AndroGel 1.62% | 204 | |
| Overall Study | NOT COMPLETED | AndroGel 1.62% | 42 |
Source ClinicalTrials.gov
Adverse events55
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 | VERTIGO | Ear and labyrinth disorders | AndroGel 1.62% | 1 | 246 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | AndroGel 1.62% | 1 | 246 | 1 |
| other | DIVERTICULUM GASTRIC | Gastrointestinal disorders | AndroGel 1.62% | 1 | 246 | 1 |
| other | NAUSEA | Gastrointestinal disorders | AndroGel 1.62% | 2 | 246 | 2 |
| other | VOMITING | Gastrointestinal disorders | AndroGel 1.62% | 1 | 246 | 1 |
| other | NON-CARDIAC CHEST PAIN | General disorders | AndroGel 1.62% | 1 | 246 | 1 |
| other | OEDEMA PERIPHERAL | General disorders | AndroGel 1.62% | 1 | 246 | 1 |
| other | PYREXIA | General disorders | AndroGel 1.62% | 2 | 246 | 2 |
| other | ABSCESS LIMB | Infections and infestations | AndroGel 1.62% | 1 | 246 | 1 |
| other | BRONCHITIS | Infections and infestations | AndroGel 1.62% | 1 | 246 | 1 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AndroGel 1.62% | 0 | 246 |
| Total, other adverse events | AndroGel 1.62% | 43 | 246 |
| Total, serious adverse events | AndroGel 1.62% | 8 | 246 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39385523 | DERIVED |
Source PubMed
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/NCT04274894
GET https://conductscience.org/api/trials/v1/NCT04274894/events?page=2