Trial · NCT03198728
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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 |
| OTHER_PRE_SPECIFIED | Change in Bilirubin | 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 Hematology Parameters | Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment | Safety Set | percentage of HbA1c | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Hormone Levels | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment | Safety set | mIU/mL | MEAN |
| OTHER_PRE_SPECIFIED | Change in Hormone SHBG | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment | Safety Set | nmol/L | MEAN |
| OTHER_PRE_SPECIFIED | Change in TSH (Thyrotropin) | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment | Safety Set | mU/L | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Lipid Profiles | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment | Safety Set LDL Cholesterol, Baseline = number of subjects with non-missing results | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in PSA | Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment | Safety Set | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Effect of SOV2012-F1 on Adrenal Cortical Function as Assessed by Measuring the Cortisol Response to Synthetic ACTH at Baseline in Subjects | 52 weeks | ACTH Completers Set | nmol/L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03198728/outcomes