Trial · NCT01831791
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | From Baseline (Week 0) until Week 52 | Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered | Participants | NUMBER |
| PRIMARY | Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE) | From Baseline (Week 0) until Week 52 | ITT Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit | Baseline to Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Grams per liter (g/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Hematocrit at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Proportion of red blood cells in blood | MEAN |
| PRIMARY | Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | 10^9 cells/Liter (GI/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | 10^12 cells per liter (TI/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Units per liter (U/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Micromoles per liter (µmol/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Microgram per liter (µg/L) | MEAN |
| PRIMARY | Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline | Baseline, Week 26 and 52 visits and/or early withdrawal visit | ITT Population. Only participants with a normal BL and at least one post-BL LV are analysed. ITT Population (represented by n=X in the category titles). | Participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points | Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. | Millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Mean Change From Baseline in Heart Rate at the Indicated Time Points | Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. | Beats per minute | MEAN |
| PRIMARY | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Week 26 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52 | Baseline, Week 26, and Week 52 | ITT Population. Only participants avilable at the specified time were analysed. | Hair count | MEAN |
| SECONDARY | Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52 | Baseline, Week 26, and Week 52 | ITT Population. Only participants avilable at the specified time were analysed. | microns x 10^-3 | MEAN |
| SECONDARY | Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52 | Baseline, Week 26 and Week 52 | ITT Population. Only participants avilable at the specified time were analysed. | Hair count | MEAN |
| SECONDARY | Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views | Baseline, Week 26 and Week 52 | ITT Population. Only participants avilable at the specified time were analysed. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With the Indicated Change From Baseline (BL) in the Stage of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at 26 Weeks and 52 Weeks | Baseline, Week 26 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. | Participants | NUMBER |
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
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GET https://conductscience.org/api/trials/v1/NCT01831791/outcomes