Trial · NCT01831791
A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
NCT01831791, Phase 3, Completed, GlaxoSmithKline; results first posted 2015-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia. Trials, record NCT01831791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01831791
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
- NCT number
- NCT01831791
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Alopecia
- Interventions
- Dutasteride 0.5 mg
- First posted
- 2013-04-15
- Last updated
- 2018-06-20
- Results first posted
- 2015-03-12
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | From Baseline (Week 0) until Week 52 | An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, drug-induced liver injury, breast cancer in male participants, prostate cancer, spontaneous abortion in female partner of male participants |
| 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 | An AE is considered drug-related if the relationship variable indicates so, or if the variable value is missing. Any AE with a start date on or after the treatment start date and on or before the last dose of treatment is considered on-treatment (treatment-emergent). This includes an AE with a missing onset date. Any AE which occurred, in the investigator's judgement and is possibly related to suicidality, is defined as possible suicidality-related adverse event (PSRAE). Suicidality was assessed by using the columbia-suicide severity rating scale (C-SSRS) as determined by the investigator. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. |
| Primary | Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit | Baseline to Week 52 | A qualitative breast examination was performed at Baseline (Week 0), at the Week 26 Visit and at the Week 52 Visit (and at the early withdrawal visit, if applicable). Participants were assessed for presence (reported as yes) and absence (reported as no) of palpable breast tissue (PBT) or nipple tenderness (NT) and/or clinically significant (CS) PBT or NT at Baseline (BL), at each scheduled Post-BL assessment. Change from BL in breast examination results included the number of participants with change from 'no (N)' at BL to 'yes (Y)' at any Post-BL assessment for the presence of PBT or NT, and the number of participants with change from N at BL in CS to Y at any Post-BL assessment in CS for PBT and for NT. BL value of an assessment is defined as the latest assessment on or before the BL date (latest non-missing value of either the treatment start date or the randomization date). |
| 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 | Blood samples were collected for the measurement of hemoglobin, albumin and total protein at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hemoglobin, albumin and total protein values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
| Primary | Mean Change From Baseline in Hematocrit at the Indicated Time Points | Baseline, Week 26 and 52 visits and/or early withdrawal visit | Blood samples were collected for the measurement of hematocrit at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hematocrit value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
| 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 | Blood samples were collected for the measurement of platelet count and white blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the platelet count and white blood cell count values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
| 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 | Blood samples were collected for the measurement of the red blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the red blood cell count value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
| 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 | Blood samples were collected for the measurement of ALT, ALP and AST at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the ALT, ALP and AST values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
| 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 | Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the total bilirubin and creatinine values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
| 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 | Blood samples were collected for the measurement of potassium, sodium, glucose and urea/BUN at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the potassium, sodium, glucose and urea/BUN values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study \[final value\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | Dutasteride 0.5 mg | Any AE | 64 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | Dutasteride 0.5 mg | Any SAE | 2 | Participants | |
| Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE) | Dutasteride 0.5 mg | Any drug related AEs | 20 | Participants | |
| Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE) | Dutasteride 0.5 mg | Any treatment-emergent AEs | 64 | Participants | |
| Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE) | Dutasteride 0.5 mg | Any AE leading to study drug discontinuation | 0 | Participants | |
| Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE) | Dutasteride 0.5 mg | Any PSRAE | 3 | Participants | |
| Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit | Dutasteride 0.5 mg | PBT, Change from N at BL to Y, n=120 | 0 | Participants | |
| Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit | Dutasteride 0.5 mg | PBT, CS, Y (among change from N at BL to Y), n=0 | 0 | Participants | |
| Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit | Dutasteride 0.5 mg | PBT, CS, N (among change from N at BL to Y), n=0 | 0 | Participants | |
| Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit | Dutasteride 0.5 mg | NT, Change from N at BL to Y, n=120 | 1 | Participants |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dutasteride 0.5 mg | 120 | |
| Overall Study | COMPLETED | Dutasteride 0.5 mg | 110 | |
| Overall Study | NOT COMPLETED | Dutasteride 0.5 mg | 10 |
Source ClinicalTrials.gov
Adverse events5
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 | Nasopharyngitis | Infections and infestations | Dutasteride 0.5 mg | 18 | 120 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.5 mg | 14 | 120 | |
| other | Libido decreased | Psychiatric disorders | Dutasteride 0.5 mg | 10 | 120 | |
| serious | Stress fracture | Injury, poisoning and procedural complications | Dutasteride 0.5 mg | 1 | 120 | |
| serious | Post-traumatic neck syndrome | Injury, poisoning and procedural complications | Dutasteride 0.5 mg | 1 | 120 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dutasteride 0.5 mg | ||
| Total, other adverse events | Dutasteride 0.5 mg | 31 | 120 |
| Total, serious adverse events | Dutasteride 0.5 mg | 2 | 120 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26893187 | 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/NCT01831791
GET https://conductscience.org/api/trials/v1/NCT01831791/registered?page=2