Trial Outcomes & Findings for A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia (NCT NCT01831791)
NCT ID: NCT01831791
Last Updated: 2018-06-20
Results Overview
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
COMPLETED
PHASE3
120 participants
From Baseline (Week 0) until Week 52
2018-06-20
Participant Flow
Male participants with androgenetic alopecia types III vertex IV and V per Norwood Hamilton classification were enrolled into study.
This outpatient study consisted of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks).
Participant milestones
| Measure |
Dutasteride 0.5 mg
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Dutasteride 0.5 mg
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
Baseline Characteristics
A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
Baseline characteristics by cohort
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Age, Continuous
|
42.2 Years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 0) until Week 52Population: Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered
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
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Any AE
|
64 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Any SAE
|
2 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 0) until Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)
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)
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)
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)
Any PSRAE
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit
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
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
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
NT, Change from N at BL to Y, n=120
|
1 Participants
|
|
Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit
NT, CS, Y (among change from N at BL to Y), n=1
|
1 Participants
|
|
Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit
NT, CS, N (among change from N at BL to Y), n=0
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Hemoglobin, Week 26, n=114
|
0.61 Grams per liter (g/L)
Standard Deviation 5.891
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Hemoglobin, Week 52, n=111
|
-0.94 Grams per liter (g/L)
Standard Deviation 5.657
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Hemoglobin, Final value, n=118
|
-0.69 Grams per liter (g/L)
Standard Deviation 5.792
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Albumin, Week 26, n=114
|
-0.64 Grams per liter (g/L)
Standard Deviation 2.014
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Albumin, Week 52, n=111
|
-1.42 Grams per liter (g/L)
Standard Deviation 1.928
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Albumin, Final value, n=118
|
-1.31 Grams per liter (g/L)
Standard Deviation 1.969
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Total protein, Week 26, n=114
|
-0.17 Grams per liter (g/L)
Standard Deviation 3.741
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Total protein, Week 52, n=111
|
-0.55 Grams per liter (g/L)
Standard Deviation 3.389
|
|
Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Total protein, Final value, n=118
|
-0.40 Grams per liter (g/L)
Standard Deviation 3.415
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Hematocrit at the Indicated Time Points
Week 26, n=114
|
-0.01 Proportion of red blood cells in blood
Standard Deviation 0.018
|
|
Mean Change From Baseline in Hematocrit at the Indicated Time Points
Week 52, n=111
|
0.00 Proportion of red blood cells in blood
Standard Deviation 0.019
|
|
Mean Change From Baseline in Hematocrit at the Indicated Time Points
Final value, n=118
|
-0.00 Proportion of red blood cells in blood
Standard Deviation 0.019
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
Platelet count, Week 26, n=114
|
3.41 10^9 cells/Liter (GI/L)
Standard Deviation 22.172
|
|
Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
Platelet count,Week 52, n=109
|
-1.48 10^9 cells/Liter (GI/L)
Standard Deviation 22.327
|
|
Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
Platelet count,Final value, n=118
|
-1.12 10^9 cells/Liter (GI/L)
Standard Deviation 22.758
|
|
Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
White blood cells count, Week 26, n=114
|
0.05 10^9 cells/Liter (GI/L)
Standard Deviation 1.309
|
|
Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
White blood cells count, Week 52, n=111
|
0.17 10^9 cells/Liter (GI/L)
Standard Deviation 1.269
|
|
Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
White blood cells count, Final value, n=118
|
0.13 10^9 cells/Liter (GI/L)
Standard Deviation 1.197
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points
Week 26, n=114
|
-0.01 10^12 cells per liter (TI/L)
Standard Deviation 0.200
|
|
Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points
Week 52, n=111
|
0.01 10^12 cells per liter (TI/L)
Standard Deviation 0.192
|
|
Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points
Final value, n=118
|
0.01 10^12 cells per liter (TI/L)
Standard Deviation 0.198
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
ALT, Week 26, n=114
|
5.58 Units per liter (U/L)
Standard Deviation 13.697
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
ALT, Week 52, n=111
|
1.51 Units per liter (U/L)
Standard Deviation 8.516
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
ALT, Final value, n=118
|
1.14 Units per liter (U/L)
Standard Deviation 7.982
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
ALP, Week 26, n=114
|
0.30 Units per liter (U/L)
Standard Deviation 10.124
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
ALP, Week 52, n=111
|
0.24 Units per liter (U/L)
Standard Deviation 9.077
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
ALP, Final value, n=118
|
0.24 Units per liter (U/L)
Standard Deviation 9.320
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
AST, Week 26, n=113
|
4.81 Units per liter (U/L)
Standard Deviation 12.164
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
AST, Week 52, n=108
|
1.85 Units per liter (U/L)
Standard Deviation 5.263
|
|
Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
AST, Final value, n=118
|
1.71 Units per liter (U/L)
Standard Deviation 4.982
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Total bilirubin, Week 26, n=114
|
-0.99 Micromoles per liter (µmol/L)
Standard Deviation 4.495
|
|
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Total bilirubin,, Week 52, n=111
|
-0.23 Micromoles per liter (µmol/L)
Standard Deviation 5.189
|
|
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Total bilirubin, Final value, n=118
|
-0.26 Micromoles per liter (µmol/L)
Standard Deviation 5.302
|
|
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Creatinine, Week 26, n=114
|
-1.14 Micromoles per liter (µmol/L)
Standard Deviation 5.525
|
|
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Creatinine, Week 52, n=111
|
1.73 Micromoles per liter (µmol/L)
Standard Deviation 6.514
|
|
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Creatinine, Final value, n=118
|
1.29 Micromoles per liter (µmol/L)
Standard Deviation 6.525
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Potassium, Week 26, n=113
|
0.08 Millimoles per liter (mmol/L)
Standard Deviation 0.289
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Potassium,, Week 52, n=108
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.308
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Potassium, Final value, n=118
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.309
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Sodium, Week 26, n=114
|
1.22 Millimoles per liter (mmol/L)
Standard Deviation 1.857
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Sodium, Week 52, n=111
|
1.01 Millimoles per liter (mmol/L)
Standard Deviation 2.143
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Sodium, Final value, n=118
|
1.02 Millimoles per liter (mmol/L)
Standard Deviation 2.152
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Glucose, Week 26, n=114
|
0.48 Millimoles per liter (mmol/L)
Standard Deviation 0.867
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Glucose, Week 52, n=111
|
0.44 Millimoles per liter (mmol/L)
Standard Deviation 0.822
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Glucose, Final value, n=118
|
0.45 Millimoles per liter (mmol/L)
Standard Deviation 0.822
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Urea/BUN , Week 26, n=114
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 1.175
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Urea/BUN , Week 52, n=111
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 1.056
|
|
Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Urea/BUN , Final value, n=118
|
0.00 Millimoles per liter (mmol/L)
Standard Deviation 1.106
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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.
Blood samples were collected for the measurement of prostate-specific antigen at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the prostate-specific antigen 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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points
Week 52, n=111
|
-0.32 Microgram per liter (µg/L)
Standard Deviation 0.582
|
|
Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points
Final value, n=118
|
-0.32 Microgram per liter (µg/L)
Standard Deviation 0.556
|
|
Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points
Week 26, n=116
|
-0.29 Microgram per liter (µg/L)
Standard Deviation 0.550
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and 52 visits and/or early withdrawal visitPopulation: 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).
Blood samples for the assessment of the indicated laboratory parameters were taken at the Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. The laboratory parameters included ALP, ALT, AST, total bilirubin, total protein, sodium, potassium, albumin, glucose, creatinine, urea/BUN, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, and prostate-specific antigen (PSA). A laboratory value (LV) that is within the normal range is considered normal. A LV that is above the upper limit of the normal range is considered high abnormal. A LV that is below the lower limit of the normal range is considered low abnormal. Number of participants with any LV shifts from BL at any time post-BL are presented for, normal at BL to abnormal; normal at BL to high; normal at BL to low; normal or low at BL to high; normal or high at BL to low.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=118 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALP, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hemoglobin, normal at BL to abnormal, n=98
|
8 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hematocrit, normal at BL to abnormal, n=95
|
8 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Platelet count, normal at BL to abnormal, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
RBC count, normal at BL to abnormal, n=99
|
11 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
WBC count, normal at BL to abnormal, n=117
|
3 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Albumin, normal at BL to abnormal, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALP, normal at BL to abnormal, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALT, normal at BL to abnormal, n=116
|
7 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
AST, normal at BL to abnormal, n=118
|
6 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Bilirubin, normal at BL to abnormal, n=104
|
5 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Creatinine, normal at BL to abnormal, n=99
|
10 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Glucose, normal at BL to abnormal, n=116
|
14 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Potassium, normal at BL to abnormal, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Protein, normal at BL to abnormal, n=118
|
2 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Sodium, normal at BL to abnormal, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Urea/BUN, normal at BL to abnormal, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
PSA, normal at BL to abnormal, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hemoglobin, normal at BL to high, n=98
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hematocrit, normal at BL to high, n=95
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Platelet count, normal at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
RBC count, normal at BL to high, n=99
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
WBC count, normal at BL to high, n=117
|
3 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Albumin, normal at BL to high, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALP, normal at BL to high, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALT, normal at BL to high, n=116
|
7 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
AST, normal at BL to high, n=118
|
6 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Bilirubin, normal at BL to high, n=104
|
5 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Creatinine, normal at BL to high, n=99
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Glucose, normal at BL to high, n=116
|
14 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Potassium, normal at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Protein, normal at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Sodium, normal at BL to high, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Urea/BUN, normal at BL to high, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
PSA, normal at BL to high, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hemoglobin, normal at BL to low, n=98
|
8 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hematocrit, normal at BL to low, n=95
|
8 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Platelet count, normal at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
RBC count, normal at BL to low, n=99
|
11 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
WBC count, normal at BL to low, n=117
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Albumin, normal at BL to low, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALP, normal at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALT, normal at BL to low, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
AST, normal at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Bilirubin, normal at BL to low, n=104
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Creatinine, normal at BL to low, n=99
|
10 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Glucose, normal at BL to low, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Potassium, normal at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Protein, normal at BL to low, n=118
|
2 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Sodium, normal at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Urea/BUN, normal at BL to low, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
PSA, normal at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hemoglobin, normal or low at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hematocrit, normal or low at BL to high, n=106
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Platelet count, normal or low at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
RBC count, normal or low at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
WBC count, normal or low at BL to high, n=118
|
3 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Albumin, normal or low at BL to high, n=116
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALP, normal or low at BL to high, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALT, normal or low at BL to high, n=116
|
7 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
AST, normal or low at BL to high, n=118
|
6 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Bilirubin, normal or low at BL to high n=104
|
5 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Creatinine, normal or low at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Glucose, normal or low at BL to high, n=117
|
14 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Potassium, normal or low at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Protein, normal or low at BL to high, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Sodium, normal or low at BL to high, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Urea/BUN, normal or low at BL to high, n=117
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
PSA, normal or low at BL to high, n=118
|
1 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hemoglobin, normal or high at BL to low, n=98
|
8 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hematocrit, normal or high at BL to low, n=107
|
8 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Platelet count, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
RBC count, normal or high at BL to low, n=99
|
11 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
WBC count, normal or high at BL to low, n=117
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Albumin, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
ALT, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
AST, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Bilirubin, normal or high at BL to low,n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Creatinine, normal or high at BL to low, n=99
|
10 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Glucose, normal or high at BL to low, n=117
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Potassium, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Total Protein, normal or high at BL to low, n=118
|
2 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Sodium, normal or high at BL to low, n=118
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Urea/BUN, normal or high at BL to low, n=117
|
0 Participants
|
|
Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
PSA, normal or high at BL to low, n=118
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visitPopulation: 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.
Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in SBP and DBP 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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 13, n=120
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 8.80
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 26, n=116
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 9.30
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 39, n=112
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 8.70
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 52, n=111
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 9.36
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Final value, n=120
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 9.47
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 13, n=120
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 7.78
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 26, n=116
|
1.9 Millimeters of mercury (mmHg)
Standard Deviation 7.35
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 39, n=112
|
0.4 Millimeters of mercury (mmHg)
Standard Deviation 7.61
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 52, n=111
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 7.44
|
|
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Final value, n=120
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.50
|
PRIMARY outcome
Timeframe: Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visitPopulation: 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.
Vital sign monitoring included heart rate measurement at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in heart rate 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).
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline in Heart Rate at the Indicated Time Points
Week 13, n=120
|
0.3 Beats per minute
Standard Deviation 8.27
|
|
Mean Change From Baseline in Heart Rate at the Indicated Time Points
Week 26, n=116
|
0.6 Beats per minute
Standard Deviation 8.30
|
|
Mean Change From Baseline in Heart Rate at the Indicated Time Points
Week 39, n=112
|
2.7 Beats per minute
Standard Deviation 9.33
|
|
Mean Change From Baseline in Heart Rate at the Indicated Time Points
Week 52, n=111
|
-0.3 Beats per minute
Standard Deviation 7.84
|
|
Mean Change From Baseline in Heart Rate at the Indicated Time Points
Final value, n=120
|
-0.6 Beats per minute
Standard Deviation 7.87
|
PRIMARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: 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.
The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants answering yes/no responses to questions about suicidal ideation (Question \[Que\] 1 and Que 2) at Baseline and post-Baseline (since last visit) and suicidal behaviors (Que 6 - Que 10) at post-Baseline (since last visit) are presented. Questions included the presence (yes) or absence (no) of the following: Que 1 - a wish to be dead; Que 2 - nonspecific (NS) active suicidal thoughts; Que 6 - preparatory acts or behavior; Que 7 - aborted attempt; Que 8 - interrupted attempt (int. att.); Que 9 - non-fatal actual suicide attempt; Que 10 - completed suicide and non-suicidal self-injurious behavior. Final assessment (FA) is the last post-Baseline measurement during the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52 preparatory acts or behavior, n=111
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, aborted attempt, n=111
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, interrupted attempt n=111
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, non-fatal actual suicide attempt, n=111
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, completed suicide, n=111
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, non-suicidal self-injurious, n=111
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, wish to be dead, n=118
|
3 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, NS active suicidal thoughts, n=118
|
1 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA preparatory acts or behavior, n=118
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, aborted attempt, n=118
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, int. att., n=118
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, non-fatal actual suicide attempt, n=118
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, completed suicide, n=118
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
FA, non-suicidal self-injurious, n=118
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
BL, wish to be dead, n=103
|
2 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
BL, NS active suicidal thoughts, n=103
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, wish to be dead, n=116
|
2 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, NS active suicidal thoughts, n=116
|
1 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26 preparatory acts or behavior, n=116
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, aborted attempt, n=116
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, int. att., n=116
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, non-fatal actual suicide attempt, n=116
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, completed suicide, n=116
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 26, non-suicidal self-injurious, n=116
|
0 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, wish to be dead, n=111
|
1 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 52, NS active suicidal thoughts, n=111
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26, and Week 52Population: ITT Population. Only participants avilable at the specified time were analysed.
Target area hair count is based on the nonvellus hair(\>= 30 micrometer\[μm\] in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as post-BL value minus BL value. The BL value is defined as the latest assessment on or before the BL date(latest non-missing value of either treatment start date or randomization date). The last observation carried forward(LOCF) method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=110 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52
Week 26 LOCF
|
87.3 Hair count
Standard Deviation 81.14
|
|
Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52
Week 52 LOCF
|
68.1 Hair count
Standard Deviation 82.14
|
SECONDARY outcome
Timeframe: Baseline, Week 26, and Week 52Population: ITT Population. Only participants avilable at the specified time were analysed.
Target area hair width was based on the total width of the nonvellus hairs(\>=30μm in width) within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. The 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). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=110 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52
Week 26 LOCF
|
6.7 microns x 10^-3
Standard Deviation 4.80
|
|
Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52
Week 52 LOCF
|
6.5 microns x 10^-3
Standard Deviation 5.29
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: ITT Population. Only participants avilable at the specified time were analysed.
Terminal hair count was based on the terminal hair(\>=60 μm in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. 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). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment for participants with missing data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=110 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52
Week 26 LOCF
|
60.8 Hair count
Standard Deviation 70.22
|
|
Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52
Week 52 LOCF
|
76.9 Hair count
Standard Deviation 86.19
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: ITT Population. Only participants avilable at the specified time were analysed.
A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 26 and Week 52 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline (Screening) with those subsequently obtained at Week 26 and Week 52. This assessment was made separately based on the global photography of the vertex and frontal views. The LOCF method for missing data was used for the assessment, if a participants was missing the Week 26 global photograph, but has a global photograph from an earlier assessment (i.e., a withdrawal visit), then that photograph was assessed during the panel review.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=117 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views
Week 26 LOCF, vertex view
|
1.34 Scores on a scale
Standard Deviation 0.921
|
|
Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views
Week 26 LOCF, frontal view
|
1.21 Scores on a scale
Standard Deviation 0.963
|
|
Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views
Week 52 LOCF, vertex view
|
1.50 Scores on a scale
Standard Deviation 0.897
|
|
Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views
Week 52 LOCF, frontal view
|
1.40 Scores on a scale
Standard Deviation 0.974
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: 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.
The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness \[MPB\]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than Stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Screening (Baseline), Week 26, and Week 52. "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. The number of participants with stage changes from Baseline are summarized. The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
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 BL Stage IIIv to W26 Stage I, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W26 Stage II, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W26 Stage IIa, n=53
|
2 Participants
|
|
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
BL Stage IIIv to W26 Stage III, n=53
|
4 Participants
|
|
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
BL Stage IIIv to W26 Stage IIIa, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W26 Stage IIIv, n=53
|
45 Participants
|
|
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
BL Stage IIIv to W26 Stage IV, n=53
|
2 Participants
|
|
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
BL Stage IIIv to W26 Stage IVa, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W26 Stage V, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W26 Stage Va, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W26 Stage VI, n=53
|
0 Participants
|
|
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
BL Stage IV to W26 Stage I, n=46
|
0 Participants
|
|
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
BL Stage IV to W26 Stage II, n=46
|
0 Participants
|
|
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
BL Stage V to W26 Stage IV, n=19
|
10 Participants
|
|
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
BL Stage V to W26 Stage IVa, n=19
|
0 Participants
|
|
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
BL Stage V to W26 Stage V, n=19
|
5 Participants
|
|
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
BL Stage V to W26 Stage Va, n=19
|
0 Participants
|
|
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
BL Stage V to W26 Stage VI, n=19
|
0 Participants
|
|
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
BL Stage IIIv to W52 Stage I, n=53
|
1 Participants
|
|
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
BL Stage IV to W26 Stage IIa, n=46
|
0 Participants
|
|
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
BL Stage IV to W26 Stage III, n=46
|
1 Participants
|
|
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
BL Stage IV to W26 Stage IIIa, n=46
|
0 Participants
|
|
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
BL Stage IV to W26 Stage IIIv, n=46
|
15 Participants
|
|
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
BL Stage IV to W26 Stage IV, n=46
|
29 Participants
|
|
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
BL Stage IV to W26 Stage IVa, n=46
|
0 Participants
|
|
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
BL Stage IV to W26 Stage V, n=46
|
0 Participants
|
|
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
BL Stage IV to W26 Stage Va, n=46
|
0 Participants
|
|
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
BL Stage IV to W26 Stage VI, n=46
|
1 Participants
|
|
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
BL Stage V to W26 Stage I, n=19
|
0 Participants
|
|
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
BL Stage V to W26 Stage II, n=19
|
0 Participants
|
|
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
BL Stage V to W26 Stage IIa, n=19
|
0 Participants
|
|
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
BL Stage V to W26 Stage III, n=19
|
1 Participants
|
|
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
BL Stage V to W26 Stage IIIa, n=19
|
0 Participants
|
|
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
BL Stage V to W26 Stage IIIv, n=19
|
3 Participants
|
|
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
BL Stage IIIv to W52 Stage II, n=53
|
2 Participants
|
|
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
BL Stage IIIv to W52 Stage IIa, n=53
|
4 Participants
|
|
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
BL Stage IIIv to W52 Stage III, n=53
|
14 Participants
|
|
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
BL Stage IIIv to W52 Stage IIIa, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W52 Stage IIIv, n=53
|
28 Participants
|
|
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
BL Stage IIIv to W52 Stage IV, n=53
|
4 Participants
|
|
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
BL Stage IIIv to W52 Stage IVa, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W52 Stage V, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W52 Stage Va, n=53
|
0 Participants
|
|
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
BL Stage IIIv to W52 Stage VI, n=53
|
0 Participants
|
|
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
BL Stage IV to W52 Stage I, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage II, n=46
|
1 Participants
|
|
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
BL Stage IV to W52 Stage IIa, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage III, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage IIIa, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage IIIv, n=46
|
19 Participants
|
|
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
BL Stage IV to W52 Stage IV, n=46
|
26 Participants
|
|
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
BL Stage IV to W52 Stage IVa, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage V, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage Va, n=46
|
0 Participants
|
|
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
BL Stage IV to W52 Stage VI, n=46
|
0 Participants
|
|
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
BL Stage V to W52 Stage I, n=19
|
0 Participants
|
|
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
BL Stage V to W52 Stage II, n=19
|
0 Participants
|
|
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
BL Stage V to W52 Stage IIa, n=19
|
0 Participants
|
|
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
BL Stage V to W52 Stage III, n=19
|
2 Participants
|
|
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
BL Stage V to W52 Stage IIIa, n=19
|
0 Participants
|
|
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
BL Stage V to W52 Stage IIIv, n=19
|
4 Participants
|
|
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
BL Stage V to W52 Stage IV, n=19
|
10 Participants
|
|
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
BL Stage V to W52 Stage IVa, n=19
|
0 Participants
|
|
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
BL Stage V to W52 Stage V, n=19
|
3 Participants
|
|
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
BL Stage V to W52 Stage Va, n=19
|
0 Participants
|
|
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
BL Stage V to W52 Stage VI, n=19
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 26, Week 39 and Week 52Population: ITT Population
The Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) questionnaire was used to assess participant-perceived problems in sexual function using 3 questions assessing problems with sex drive, erections and ejaculation. They are scored on a 5-point scale of 0 to 4 (0=big problem, 1= medium problem, 2=small problem, 3=very small problem, 4=no problem). Total scores range from 0-12. Change from Baseline in PAS SFI scores is defined 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). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52
Week 13 LOCF
|
-0.6 Scores on a scale
Standard Deviation 2.30
|
|
Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52
Week 26 LOCF
|
-0.7 Scores on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52
Week 39 LOCF
|
-0.3 Scores on a scale
Standard Deviation 1.97
|
|
Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52
Week 52 LOCF
|
-0.3 Scores on a scale
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 26, Week 39, and Week 52Population: ITT Population
The DLQI is a 10-item validated measure developed specifically to assess quality of life (QoL) in participants with dermatological conditions. It assesses six domains: symptoms and feelings, daily activities, leisure, work ⁄school, personal relationships, and treatment. The DLQI total is the sum of 10 questions, each ranging from 0 (unanswered/not relevant,not at all) to 3 (very much). The higher the score, the greater the impairment of (QoL). Change from Baseline in DLQI scores is defined 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). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52
Week 13 LOCF
|
-0.15 Scores on a scale
Standard Deviation 1.281
|
|
Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52
Week 26 LOCF
|
-0.25 Scores on a scale
Standard Deviation 1.367
|
|
Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52
Week 39 LOCF
|
-0.27 Scores on a scale
Standard Deviation 1.465
|
|
Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52
Week 52 LOCF
|
-0.23 Scores on a scale
Standard Deviation 1.393
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: 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.
Blood samples for DHT analysis was collected at Baseline, Week 26 and Week 52. DHT values at a lower limit of quantification (LLQ) were imputed using 1/2 LLQ. 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). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=120 Participants
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks
Baseline, n=120
|
1.55 nanomole per liter (nmol/L)
Standard Deviation 0.714
|
|
Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks
Week 26 LOCF, n=118
|
0.19 nanomole per liter (nmol/L)
Standard Deviation 0.518
|
|
Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks
Week 52 LOCF, n=118
|
0.17 nanomole per liter (nmol/L)
Standard Deviation 0.267
|
Adverse Events
Dutasteride 0.5 mg
Serious adverse events
| Measure |
Dutasteride 0.5 mg
n=120 participants at risk
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.83%
1/120 • Serious adverse events (SAE) and non-serious adverse events (AE) are reported from the start of treatment until the last dose of treatment.
SAEs and non-serious AEs are summarized for members of the ITT Population, comprised of all participants who received a randomization number, regardless of whether or not treatment was administered. This also includes AEs with missing onset date.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.83%
1/120 • Serious adverse events (SAE) and non-serious adverse events (AE) are reported from the start of treatment until the last dose of treatment.
SAEs and non-serious AEs are summarized for members of the ITT Population, comprised of all participants who received a randomization number, regardless of whether or not treatment was administered. This also includes AEs with missing onset date.
|
Other adverse events
| Measure |
Dutasteride 0.5 mg
n=120 participants at risk
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.0%
18/120 • Serious adverse events (SAE) and non-serious adverse events (AE) are reported from the start of treatment until the last dose of treatment.
SAEs and non-serious AEs are summarized for members of the ITT Population, comprised of all participants who received a randomization number, regardless of whether or not treatment was administered. This also includes AEs with missing onset date.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
11.7%
14/120 • Serious adverse events (SAE) and non-serious adverse events (AE) are reported from the start of treatment until the last dose of treatment.
SAEs and non-serious AEs are summarized for members of the ITT Population, comprised of all participants who received a randomization number, regardless of whether or not treatment was administered. This also includes AEs with missing onset date.
|
|
Psychiatric disorders
Libido decreased
|
8.3%
10/120 • Serious adverse events (SAE) and non-serious adverse events (AE) are reported from the start of treatment until the last dose of treatment.
SAEs and non-serious AEs are summarized for members of the ITT Population, comprised of all participants who received a randomization number, regardless of whether or not treatment was administered. This also includes AEs with missing onset date.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER