Trial · NCT03198728
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
NCT03198728, Phase 3, Completed, Marius Pharmaceuticals; results first posted 2023-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men. Trials, record NCT03198728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03198728
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
- NCT number
- NCT03198728
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 314 participants, actual
- Lead sponsor
- Marius Pharmaceuticals
- Conditions
- Hypogonadism, Male
- Interventions
- SOV2012-F1, AndroGel
- First posted
- 2017-06-26
- Last updated
- 2023-06-28
- Results first posted
- 2023-06-28
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1. | 90 days | Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values. |
| Secondary | Percentages of Participants in Each Category for Maximum Plasma Concentration | 90 days | To determine the percentage of treated subjects with maximum plasma testosterone concentration (T Cmax) values (a) \< 1.5X Upper Limit of Normal (ULN); (b) 1.8X to 2.5X ULN; and (c) \> 2.5X ULN. For NaF/EDTA plasma, thresholds are 1200, 1440 and 2000 ng/dL of T. For serum, thresholds are 1500, 1800 and 2500 ng/dL of T. Note that the endpoint concerns only the investigational treatment SOV2012-F1 and the AndroGel results are reported for completeness. The reported percentages do not sum to 100% as the FDA criteria do not specify the percentage of subjects in the window of ≥ 1.5X and ≤ 1.8X the ULN. |
| Other | Change From Baseline in the IPSS | Baseline (pre-treatment) to 90 days and 365 days | Patient reported outcomes will be assessed by the International Prostate Symptom Score (I-PSS) Reporting a score on a scale 0 to 35 (asymptomatic to very symptomatic). Mean change from baseline is reported and is the difference between the score at Baseline (pre-treatment) and at Day 90 and Day 365. Thus, a positive value at Day 90 or Day 365 represents an increase in the score from baseline. |
| Other | Change From Baseline in the Psychosexual Daily Questionnaire (PDQ) | Baseline (pre-treatment) to 90 days and 365 days | Patient reported outcomes are 7-day average score at baseline, and average change from baseline (CfB) at Day 90 and Day 365. Weekly daily average scores calculated for diaries completed at least 3 of 7 days. The three domains are: Sexual desire subscale 0=None, 1=very low to 7=Very High. Sexual enjoyment with/without partner subscale 0=None to 7=Very high enjoyment/pleasure. Partner availability not used in scoring. Positive CfB desirable. Positive and negative mood subscales 0=Not at all true to 7=Very true (Likert 7-point scale, 7-day average reported). Positive mood (sum of 4 questions) score range = 0 to 28; positive changes from baseline desirable. Negative mood (sum of 5 questions) score range = 0 to 35; negative CfB desirable. Weekly sexual activity subscale score is 7\*(# of activities per week / # of days reported). Percent full erection uses scale of 0-100% (10% steps). Satisfaction with erection 0=not satisfactory to 7=very satisfactory. Positive CfB desirable. |
| Other | Change From Baseline in the SF-36 | Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT) | Patient reported outcomes assessed by the Short-Form Survey (SF-36). This scale assesses 8 health concepts: 1. limitations in physical activities because of health problems 2. limitations in social activities because of physical or emotional problems 3. limitations in usual role activities because of physical health problems 4. bodily pain 5. general mental health (psychological distress and well-being) 6. limitations in usual role activities because of emotional problems 7. vitality (energy and fatigue) 8. general health perceptions. Each domain is scored from 0-100 with a score of 0 = maximum disability and a score of 100 = no disability. End of Treatment (EOT) occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure towards less disability. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and EOT scores. |
| Other | Change From Baseline in the IIEF | Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT) | Patient reported outcomes are assessed by the International Index of Erectile Function (IIEF). A score of 0-5 (higher score indicating improvement) is awarded to each of the 15 questions that examine overall satisfaction (2 questions, total possible score=10), and the 4 main domains of male sexual function: erectile function (6 questions, total possible score=30), orgasmic function (2 questions, total possible score=10), sexual desire (2 questions, total possible score=10), and intercourse satisfaction (3 questions, total possible score=15). The IIEF results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment (EOT). EOT occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and End of Treatment scores. |
| Other | Change From Baseline in Fasting Serum Glucose (FSG) Concentration | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | The measured value is the FSG concentration reported as mg/dL. The FSG results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values. |
| Other | Change From Baseline in Fasting Insulin Concentration | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | The measured value is the insulin concentration reported as in units of uU/mL. The insulin results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values. |
| Other | Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | Changes from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), as mmHg. The blood pressure results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the measured SBP or DBP. |
| Other | Change From Baseline in Liver Function Tests | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | Liver function tests (ALT, AST, total bilirubin, alkaline phosphatase). The liver function test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the liver function test value |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1. | 90 days | Efficacy Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentages of Participants in Each Category for Maximum Plasma Concentration | 90 days | Full Analysis Set | percentage of actual number of subjects | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in the IPSS | Baseline (pre-treatment) to 90 days and 365 days | Full Analysis Set | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the Psychosexual Daily Questionnaire (PDQ) | Baseline (pre-treatment) to 90 days and 365 days | Full Analysis Set | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the SF-36 | Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT) | Full Analysis Set | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the IIEF | Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT) | Full Analysis Set | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Fasting Serum Glucose (FSG) Concentration | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | Safety Set | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Fasting Insulin Concentration | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | Safety Set | uU/mL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | Safety Set | mmHg | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Liver Function Tests | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. | Safety set | U/L | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group313
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1. | SOV2012-F1 Treated | 166 | Participants | ||
| Percentages of Participants in Each Category for Maximum Plasma Concentration | SOV2012-F1 Treated | T Cmax < 1200 ng/dL for SOV2012-F1; T Cmax < 1500 ng/dL for Andro-gel after 90 days | 76.9 | percentage of actual number of subjects | |
| Percentages of Participants in Each Category for Maximum Plasma Concentration | Andro-gel™ Treated | T Cmax < 1200 ng/dL for SOV2012-F1; T Cmax < 1500 ng/dL for Andro-gel after 90 days | 92.2 | percentage of actual number of subjects | |
| Percentages of Participants in Each Category for Maximum Plasma Concentration | SOV2012-F1 Treated | T Cmax 1440 to 2000 ng/dL for SOV2012-F1; T Cmax 1800 to 2500 ng/dL for Andro-gel after 90 days | 7.5 | percentage of actual number of subjects | |
| Percentages of Participants in Each Category for Maximum Plasma Concentration | Andro-gel™ Treated | T Cmax 1440 to 2000 ng/dL for SOV2012-F1; T Cmax 1800 to 2500 ng/dL for Andro-gel after 90 days | 2.2 | percentage of actual number of subjects | |
| Percentages of Participants in Each Category for Maximum Plasma Concentration | SOV2012-F1 Treated | T Cmax > 2000 ng/dL for SOV2012-F1; T Cmax > 2500 ng/dL for Andro-gel after 90days | 3.2 | percentage of actual number of subjects | |
| Percentages of Participants in Each Category for Maximum Plasma Concentration | Andro-gel™ Treated | T Cmax > 2000 ng/dL for SOV2012-F1; T Cmax > 2500 ng/dL for Andro-gel after 90days | 1.1 | percentage of actual number of subjects | |
| Change From Baseline in the IPSS | SOV2012-F1 Treated | Baseline | 4.4 | Standard Deviation 4.12 | score on a scale |
| Change From Baseline in the IPSS | Andro-gel™ Treated | Baseline | 5.4 | Standard Deviation 4.94 | score on a scale |
| Change From Baseline in the IPSS | SOV2012-F1 Treated | Change from baseline (Visit 8 - Day 90) | 0.2 | Standard Deviation 3.56 | score on a scale |
1 to 10 of 313Source ClinicalTrials.gov
See all 313 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SOV2012-F1-Treated | 214 | |
| Overall Study | STARTED | Andro-Gel™ Treated | 100 | |
| Overall Study | COMPLETED | SOV2012-F1-Treated | 162 | |
| Overall Study | COMPLETED | Andro-Gel™ Treated | 76 | |
| Overall Study | NOT COMPLETED | SOV2012-F1-Treated | 52 | |
| Overall Study | NOT COMPLETED | Andro-Gel™ Treated | 24 |
Source ClinicalTrials.gov
Adverse events96
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 | Upper respiratory tract infection | Infections and infestations | SOV2012-F1-Treated | 15 | 214 | 20 |
| other | Upper respiratory tract infection | Infections and infestations | Andro-Gel Treated | 12 | 100 | 16 |
| other | Influenza | Infections and infestations | SOV2012-F1-Treated | 10 | 214 | 10 |
| other | Influenza | Infections and infestations | Andro-Gel Treated | 4 | 100 | 4 |
| other | Viral upper respiratory tract infection | Infections and infestations | SOV2012-F1-Treated | 7 | 214 | 10 |
| other | Viral upper respiratory tract infection | Infections and infestations | Andro-Gel Treated | 5 | 100 | 6 |
| other | Sinusitis | Infections and infestations | SOV2012-F1-Treated | 5 | 214 | 5 |
| other | Sinusitis | Infections and infestations | Andro-Gel Treated | 4 | 100 | 4 |
| other | Urinary tract infection | Infections and infestations | SOV2012-F1-Treated | 2 | 214 | 2 |
| other | Urinary tract infection | Infections and infestations | Andro-Gel Treated | 2 | 100 | 2 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOV2012-F1-Treated | 1 | 214 |
| Total, all-cause mortality | Andro-Gel Treated | 0 | 100 |
| Total, other adverse events | SOV2012-F1-Treated | 53 | 214 |
| Total, other adverse events | Andro-Gel Treated | 25 | 100 |
| Total, serious adverse events | SOV2012-F1-Treated | 9 | 214 |
| Total, serious adverse events | Andro-Gel Treated | 1 | 100 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SOV2012-F1-Treated vs Andro-Gel Treated: deaths from any cause | Trial comparisons |
| SOV2012-F1-Treated vs Andro-Gel Treated: serious adverse events | Trial comparisons |
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/NCT03198728
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