Trial · NCT04467697
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
NCT04467697, Phase 3, Completed, Marius Pharmaceuticals; results first posted 2024-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men. Trials, record NCT04467697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04467697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
- NCT number
- NCT04467697
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Marius Pharmaceuticals
- Conditions
- Hypogonadism, Male
- Interventions
- SOV2012-F1
- First posted
- 2020-07-13
- Last updated
- 2024-06-28
- Results first posted
- 2024-06-28
Source ClinicalTrials.gov
Registered outcomes21
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 Ambulatory Systolic Blood Pressure After 120 Days Treatment | 120 days | Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis). |
| Primary | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | 90 days | Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1. |
| Secondary | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average systolic blood pressure (sBP) after 120 and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis). |
| Secondary | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average diastolic blood pressure (dBP) after 120 Days (+/-) and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis). |
| Secondary | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis. |
| Secondary | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Observed and change from baseline in Ambulatory half hourly systolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| Secondary | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Observed and change from baseline in Ambulatory half hourly diastolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| Secondary | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 120 and 180 days | Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| Secondary | Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1. |
| Secondary | Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 Ambulatory Systolic Blood Pressure After 120 Days Treatment | 120 days | Extension Treated Set | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | 90 days | Modified Extension Treated Set | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | 120 and 180 days | Extension Treated Set | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | 120 and 180 days | Extension Treated Set | bpm | LEAST_SQUARES_MEAN |
| SECONDARY | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | mmHg | MEAN |
| SECONDARY | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | mmHg | MEAN |
| SECONDARY | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | bpm | MEAN |
| SECONDARY | Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Modified Extension Treatment Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Modified Extension Treatment Set | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group858
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 Ambulatory Systolic Blood Pressure After 120 Days Treatment | SOV2012-F1-treated | Baseline | 128.9 | 95% Confidence Interval 126.8 to 131.0 | mmHg |
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | SOV2012-F1-treated | Observed Visit 14E - Day 120E | 130.6 | 95% Confidence Interval 128.5 to 132.7 | mmHg |
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | SOV2012-F1-treated | Change from baseline (Visit 14E - Day 120E) | 1.7 | 95% Confidence Interval 0.3 to 3.1 | mmHg |
| Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | NaF/EDTA PLASMA | Worst case scenario | 87.8 | 95% Confidence Interval 82.3 to 93.2 | percentage of participants |
| Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | SERUM | Worst case scenario | 86.5 | 95% Confidence Interval 79.4 to 93.6 | percentage of participants |
| Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | NaF/EDTA PLASMA | Day 90 completers | 96.1 | 95% Confidence Interval 92.7 to 99.4 | percentage of participants |
| Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | SERUM | Day 90 completers | 87.5 | 95% Confidence Interval 80.6 to 94.4 | percentage of participants |
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | SOV2012-F1-treated | Baseline | 128.9 | 95% Confidence Interval 126.8 to 131.0 | mmHg |
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | SOV2012-F1-treated | Observed Visit 14E (Day 120E) | 130.6 | 95% Confidence Interval 128.5 to 132.7 | mmHg |
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | SOV2012-F1-treated | Change from baseline (Day 120E - Day 1E) | 1.7 | 95% Confidence Interval 0.3 to 3.1 | mmHg |
1 to 10 of 858Source ClinicalTrials.gov
See all 858 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SOV2012-F1-treated | 155 | |
| Overall Study | COMPLETED | SOV2012-F1-treated | 135 | |
| Overall Study | NOT COMPLETED | SOV2012-F1-treated | 20 |
Source ClinicalTrials.gov
Adverse events9
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 | Hypertension | Vascular disorders | SOV2012-F1-treated | 4 | 155 | 4 |
| other | Upper Respiratory Tract Infection | Infections and infestations | SOV2012-F1-treated | 8 | 155 | 8 |
| other | Viral upper respiratory tract infection | Infections and infestations | SOV2012-F1-treated | 5 | 155 | 5 |
| other | Influenza | Infections and infestations | SOV2012-F1-treated | 4 | 155 | 4 |
| other | Bronchitis | Infections and infestations | SOV2012-F1-treated | 3 | 155 | 3 |
| other | Hemoglobin increased | Investigations | SOV2012-F1-treated | 3 | 155 | 3 |
| other | Headache | Nervous system disorders | SOV2012-F1-treated | 3 | 155 | 3 |
| serious | Atrial fibrillation | Cardiac disorders | SOV2012-F1-treated | 1 | 155 | 1 |
| serious | Diverticular perforation | Gastrointestinal disorders | SOV2012-F1-treated | 1 | 155 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOV2012-F1-treated | 0 | 155 |
| Total, other adverse events | SOV2012-F1-treated | 30 | 155 |
| Total, serious adverse events | SOV2012-F1-treated | 2 | 155 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38606384 | 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.
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