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Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT01231607
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : October 4, 2012
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Androgenetic Alopecia
Interventions Drug: 1mg Finasteride active
Drug: 0.02mg dutasteride
Drug: 0.1mg dutasteride
Drug: 0.5mg dutasteride
Drug: Finasteride placebo
Drug: Dutasteride placebo
Enrollment 917
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg Placebo
Hide Arm/Group Description Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily Dutasteride 0.1 mg and finasteride placebo once daily Dutasteride 0.5 mg and finasteride placebo once daily Finasteride 1 mg and dutasteride placebo once daily Matching dutasteride placebo and finasteride placebo once daily
Period Title: Overall Study
Started 185 188 184 179 181
Completed 156 154 153 141 157
Not Completed 29 34 31 38 24
Reason Not Completed
Adverse Event             0             8             4             4             5
Lost to Follow-up             13             11             10             10             4
Physician Decision             4             4             3             5             4
Protocol Violation             3             2             0             2             2
Withdrawal by Subject             9             9             14             17             9
Arm/Group Title Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg Placebo Total
Hide Arm/Group Description Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily Dutasteride 0.1 mg and finasteride placebo once daily Dutasteride 0.5 mg and finasteride placebo once daily Finasteride 1 mg and dutasteride placebo once daily Matching dutasteride placebo and finasteride placebo once daily Total of all reporting groups
Overall Number of Baseline Participants 185 188 184 179 181 917
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 188 participants 184 participants 179 participants 181 participants 917 participants
38.5  (7.72) 38.7  (7.44) 38.6  (7.66) 38.0  (7.81) 38.7  (8.43) 38.5  (7.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 188 participants 184 participants 179 participants 181 participants 917 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
185
 100.0%
188
 100.0%
184
 100.0%
179
 100.0%
181
 100.0%
917
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 185 participants 188 participants 184 participants 179 participants 181 participants 917 participants
Asian - Japanese Heritage 40 40 40 40 39 199
American Indian or Alaskan Native 37 38 39 36 38 188
African American/African Heritage 1 0 0 0 1 2
Asian - South East Asian Heritage 44 43 42 41 41 211
Asian - East Asian Heritage 19 20 19 19 19 96
Asian - Mixed Race 0 0 0 0 1 1
White - White/Caucasian/European Heritage 44 47 44 43 42 220
1.Primary Outcome
Title Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)
Hide Description The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 148 155 158 150 141
Least Squares Mean (Standard Error)
Unit of Measure: Hair count
-4.9  (7.89) 17.1  (7.74) 63.0  (7.67) 89.6  (7.87) 56.5  (8.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.02 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares (LS) mean difference
Estimated Value 22
Confidence Interval (2-Sided) 98.33%
-4.4 to 48.4
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 67.9
Confidence Interval (2-Sided) 98.33%
41.6 to 94.2
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General linear model
Comments Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 94.4
Confidence Interval (2-Sided) 98.33%
67.8 to 121.0
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 61.4
Confidence Interval (2-Sided) 98.33%
34.4 to 88.4
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.02 mg, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -39.4
Confidence Interval 99.165%
-66.1 to -12.7
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.1 mg, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 6.5
Confidence Interval 99.165%
-20.1 to 33.1
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.5 mg, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 33
Confidence Interval 99.165%
6.1 to 60
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.02 mg, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -39.4
Confidence Interval (2-Sided) 98.33%
-66.1 to -12.7
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.1 mg, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 6.5
Confidence Interval (2-Sided) 98.33%
-20.1 to 33.1
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.5 mg, Finasteride 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 33
Confidence Interval (2-Sided) 98.33%
6.1 to 60
Estimation Comments Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.
2.Secondary Outcome
Title Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT
Hide Description The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 152 158 159 152 142
Least Squares Mean (Standard Error)
Unit of Measure: Hair count
-0.3  (1.74) 4.2  (1.71) 12.4  (1.70) 18.1  (1.74) 12.1  (1.80)
3.Secondary Outcome
Title Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT
Hide Description The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 147 144 151 145 131
Least Squares Mean (Standard Error)
Unit of Measure: Hair count
-4.0  (7.22) 22.9  (7.32) 59.6  (7.15) 82.3  (7.29) 50.9  (7.67)
4.Secondary Outcome
Title Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12
Hide Description The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 152 154 155 149 134
Least Squares Mean (Standard Error)
Unit of Measure: Hair count
-0.4  (1.63) 5.1  (1.63) 12.8  (1.62) 17.1  (1.65) 10.8  (1.74)
5.Secondary Outcome
Title Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT
Hide Description The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 148 155 158 150 141
Least Squares Mean (Standard Error)
Unit of Measure: millimeters
Week 12, n=147, 144, 151, 145, 131 -0.7  (0.40) 0.3  (0.41) 3.1  (0.40) 4.7  (0.41) 3.2  (0.43)
Week 24, n=148, 155, 158, 150, 141 -0.9  (0.45) -0.0  (0.44) 3.9  (0.44) 5.8  (0.45) 4.0  (0.46)
6.Secondary Outcome
Title Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT
Hide Description The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 152 158 159 152 142
Least Squares Mean (Standard Error)
Unit of Measure: millimeters
Week 12, n=152, 154, 155, 149, 134 -0.1  (0.09) 0.1  (0.09) 0.7  (0.09) 0.9  (0.09) 0.6  (0.10)
Week 24, n=152, 158, 159, 152, 142 -0.2  (0.10) 0.1  (0.10) 0.8  (0.10) 1.2  (0.10) 0.8  (0.10)
7.Secondary Outcome
Title Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT
Hide Description The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 148 155 158 150 141
Least Squares Mean (Standard Error)
Unit of Measure: Hair count
Week 12, n=147, 144, 151, 145, 131 -11.5  (4.39) -13.4  (4.44) 18.3  (4.35) 29.3  (4.43) 24.2  (4.67)
Week 24, n=148, 155, 158, 150, 141 -17.5  (5.13) -15.7  (5.03) 29.4  (4.99) 46  (5.11) 36.3  (5.28)
8.Secondary Outcome
Title Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT
Hide Description The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 152 158 159 152 142
Least Squares Mean (Standard Error)
Unit of Measure: Hair count
Week 12, n=152, 154, 155, 149, 134 -1.1  (1.05) -2.7  (1.05) 4.0  (1.05) 5.9  (1.06) 4.5  (1.12)
Week 24, n=152, 158, 159, 152, 142 -3.0  (1.20) -2.8  (1.18) 6.0  (1.18) 9.3  (1.20) 7.2  (1.25)
9.Secondary Outcome
Title Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately
Hide Description A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 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 with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 172 174 176 167 165
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Vertex view, n=172, 174, 176, 167, 164 -0.15  (0.056) -0.09  (0.056) 0.42  (0.055) 0.63  (0.057) 0.49  (0.057)
Frontal/Superior view, n=171, 174, 176, 167, 165 -0.14  (0.054) -0.10  (0.053) 0.36  (0.053) 0.58  (0.055) 0.34  (0.055)
10.Secondary Outcome
Title Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately
Hide Description The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 172 171 172 166 160
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Vertex view 0.48  (0.068) 0.35  (0.069) 0.62  (0.068) 0.78  (0.070) 0.70  (0.071)
Frontal view 0.30  (0.059) 0.33  (0.059) 0.54  (0.059) 0.55  (0.060) 0.55  (0.061)
11.Secondary Outcome
Title Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately
Hide Description The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 173 174 177 167 165
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Vertex view 0.36  (0.079) 0.37  (0.079) 1.03  (0.078) 1.30  (0.080) 1.07  (0.081)
Frontal view 0.30  (0.075) 0.28  (0.075) 0.78  (0.074) 1.11  (0.076) 0.88  (0.077)
12.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)
Hide Description 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 Baseline and Week 12 (W12). "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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 172 177 173 169 161
Measure Type: Number
Unit of Measure: participants
BL S IIIv to W12 S II, n=79, 70, 69, 72, 73 1 1 0 1 0
BL S IIIv to W12 S IIa, n=79, 70, 69, 72, 73 0 0 0 0 0
BL S IIIv to W12 S III, n=79, 70, 69, 72, 73 4 8 11 10 11
BL S IIIv to W12 S IIIa, n=79, 70, 69, 72, 73 0 0 1 0 0
BL S IIIv to W12 S IIIv, n=79, 70, 69, 72, 73 71 59 55 59 62
BL S IIIv to W12 S IV, n=79, 70, 69, 72, 73 2 1 2 2 0
BL S IIIv to W12 S IVa, n=79, 70, 69, 72, 73 0 0 0 0 0
BL S IIIv to W12 S V, n=79, 70, 69, 72, 73 1 1 0 0 0
BL S IIIv to W12 S Va, n=79, 70, 69, 72, 73 0 0 0 0 0
BL S IIIv to W12 S VI, n=79, 70, 69, 72, 73 0 0 0 0 0
BL S IV to W12 S II, n=52, 59, 58, 56, 53 0 0 0 0 0
BL S IV to W12 S IIa, n=52, 59, 58, 56, 53 0 0 0 0 0
BL S IV to W12 S III, n=52, 59, 58, 56, 53 2 4 1 4 1
BL S IV to W12 S IIIa, n=52, 59, 58, 56, 53 0 0 0 0 0
BL S IV to W12 S IIIv, n=52, 59, 58, 56, 53 2 3 8 5 5
BL S IV to W12 S IV, n=52, 59, 58, 56, 53 45 50 44 47 45
BL S IV to W12 S IVa, n=52, 59, 58, 56, 53 1 0 1 0 0
BL S IV to W12 S V, n=52, 59, 58, 56, 53 2 2 4 0 2
BL S IV to W12 S Va, n=52, 59, 58, 56, 53 0 0 0 0 0
BL S IV to W12 S VI, n=52, 59, 58, 56, 53 0 0 0 0 0
BL S V to W12 S II, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W12 S IIa, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W12 S III, n=41, 46, 46, 41, 35 2 1 0 1 0
BL S V to W12 S IIIa, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W12 S IIIv, n=41, 46, 46, 41, 35 0 1 3 1 0
BL S V to W12 S IV, n=41, 46, 46, 41, 35 4 4 5 5 2
BL S V to W12 S IVa, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W12 S V, n=41, 46, 46, 41, 35 35 40 38 33 33
BL S V to W12 S Va, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W12 S VI, n=41, 46, 46, 41, 35 0 0 0 1 0
13.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24
Hide Description 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 Baseline and Week 24 (W24). "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.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 173 177 177 169 165
Measure Type: Number
Unit of Measure: participants
BL S IIIv to W24 S II, n=80, 72, 72, 72, 76 3 2 2 3 2
BL S IIIv to W24 S IIa, n=80, 72, 72, 72, 76 0 0 0 1 1
BL S IIIv to W24 S III, n=80, 72, 72, 72, 76 6 8 11 13 13
BL S IIIv to W24 S IIIa, n=80, 72, 72, 72, 76 0 0 0 0 0
BL S IIIv to W24 S IIIv, n=80, 72, 72, 72, 76 67 61 58 54 59
BL S IIIv to W24 S IV, n=80, 72, 72, 72, 76 4 1 1 1 1
BL S IIIv to W24 S IVa, n=80, 72, 72, 72, 76 0 0 0 0 0
BL S IIIv to W24 S V, n=80, 72, 72, 72, 76 0 0 0 0 0
BL S IIIv to W24 S Va, n=80, 72, 72, 72, 76 0 0 0 0 0
BL S IIIv to W24 S VI, n=80, 72, 72, 72, 76 0 0 0 0 0
BL S IV to W24 S II, n=52, 59, 59, 56, 54 0 1 1 1 0
BL S IV to W24 S IIa, n=52, 59, 59, 56, 54 0 0 0 0 0
BL S IV to W24 S III, n=52, 59, 59, 56, 54 2 3 4 5 4
BL S IV to W24 S IIIa, n=52, 59, 59, 56, 54 0 0 0 2 0
BL S IV to W24 S IIIv, n=52, 59, 59, 56, 54 4 7 11 10 13
BL S IV to W24 S IV, n=52, 59, 59, 56, 54 44 46 39 37 36
BL S IV to W24 S IVa, n=52, 59, 59, 56, 54 0 0 0 1 0
BL S IV to W24 S V, n=52, 59, 59, 56, 54 2 2 4 0 1
BL S IV to W24 S Va, n=52, 59, 59, 56, 54 0 0 0 0 0
BL S IV to W24 S VI, n=52, 59, 59, 56, 54 0 0 0 0 0
BL S V to W24 S II, n=41, 46, 46, 41, 35 0 1 0 0 0
BL S V to W12 S IIa, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W24 S III, n=41, 46, 46, 41, 35 2 1 1 3 1
BL S V to W24 S IIIa, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W24 S IIIv, n=41, 46, 46, 41, 35 3 1 4 3 1
BL S V to W24 S IV, n=41, 46, 46, 41, 35 7 10 8 10 8
BL S V to W24 S IVa, n=41, 46, 46, 41, 35 0 0 0 0 1
BL S V to W24 S V, n=41, 46, 46, 41, 35 29 33 33 25 24
BL S V to W24 S Va, n=41, 46, 46, 41, 35 0 0 0 0 0
BL S V to W24 S VI, n=41, 46, 46, 41, 35 0 0 0 0 0
14.Secondary Outcome
Title Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)
Hide Description Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).
Time Frame Week 12, Week 24, and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.
Arm/Group Title Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg
Hide Arm/Group Description:
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Overall Number of Participants Analyzed 172 172 165
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Week 12, n=172, 172, 165 0.2  (1.96) 2.1  (1.72) 33.2  (20.10)
Week 24, n=158, 158, 153 0.0  (0.14) 2.0  (1.90) 36.1  (23.21)
Week 26, n=156, 154, 152 0.1  (0.84) 0.3  (0.69) 21.1  (17.65)
15.Secondary Outcome
Title Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)
Hide Description Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).
Time Frame Week 12, Week 24, and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 173 177 177 171 165
Mean (Standard Deviation)
Unit of Measure: nanomoles per liter (nmol/L)
Week 12, n=172, 174, 172, 170, 161 1.17  (0.531) 0.88  (0.519) 0.39  (0.402) 0.31  (0.374) 0.45  (0.462)
Week 24, n=173, 177, 176, 170, 165 1.16  (0.482) 1.01  (0.540) 0.49  (0.500) 0.31  (0.402) 0.49  (0.500)
Week 26, n=173, 177, 177, 171, 165 1.21  (0.523) 1.11  (0.600) 0.77  (0.602) 0.37  (0.451) 1.03  (0.636)
16.Secondary Outcome
Title Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24
Hide Description Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: "Since the start of treatment, when I look at my thinning area, I can see...", "Since the start of treatment, my hair now covers…", and "Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is…" -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9).
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 172 174 177 167 165
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 12, n=171, 171, 172, 166, 160 1.2  (0.19) 0.9  (0.19) 1.7  (0.19) 2.0  (0.19) 1.7  (0.20)
Week 24, n=172, 174, 177, 167, 165 1.1  (0.22) 1.1  (0.22) 2.8  (0.22) 3.2  (0.22) 2.5  (0.23)
17.Secondary Outcome
Title Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24
Hide Description Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15).
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.
Arm/Group Title Placebo Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg
Hide Arm/Group Description:
Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
Overall Number of Participants Analyzed 172 176 177 170 165
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 12, n=171, 174, 173, 170, 160 8.5  (0.54) 7.9  (0.53) 9.8  (0.53) 8.4  (0.54) 8.5  (0.55)
Week 24, n=172, 176, 177, 170, 165 9.3  (0.56) 8.3  (0.56) 11.5  (0.56) 12.5  (0.56) 10.8  (0.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg Placebo
Hide Arm/Group Description Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily Dutasteride 0.1 mg and finasteride placebo once daily Dutasteride 0.5 mg and finasteride placebo once daily Finasteride 1 mg and dutasteride placebo once daily Matching dutasteride placebo and finasteride placebo once daily
All-Cause Mortality
Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/185 (0.00%)      3/188 (1.60%)      1/184 (0.54%)      2/179 (1.12%)      2/181 (1.10%)    
Gastrointestinal disorders           
Gastric ulcer †  0/185 (0.00%)  0 0/188 (0.00%)  0 1/184 (0.54%)  1 0/179 (0.00%)  0 0/181 (0.00%)  0
Infections and infestations           
Infection parasitic †  0/185 (0.00%)  0 0/188 (0.00%)  0 1/184 (0.54%)  1 0/179 (0.00%)  0 0/181 (0.00%)  0
Laryngitis †  0/185 (0.00%)  0 0/188 (0.00%)  0 0/184 (0.00%)  0 1/179 (0.56%)  1 0/181 (0.00%)  0
Pharyngeal abscess †  0/185 (0.00%)  0 0/188 (0.00%)  0 0/184 (0.00%)  0 1/179 (0.56%)  1 0/181 (0.00%)  0
Salmonellosis †  0/185 (0.00%)  0 0/188 (0.00%)  0 1/184 (0.54%)  1 0/179 (0.00%)  0 0/181 (0.00%)  0
Injury, poisoning and procedural complications           
Cartilage injury †  0/185 (0.00%)  0 1/188 (0.53%)  1 0/184 (0.00%)  0 0/179 (0.00%)  0 0/181 (0.00%)  0
Fractured sacrum †  0/185 (0.00%)  0 0/188 (0.00%)  0 0/184 (0.00%)  0 1/179 (0.56%)  1 0/181 (0.00%)  0
Lower limb fracture †  0/185 (0.00%)  0 0/188 (0.00%)  0 0/184 (0.00%)  0 1/179 (0.56%)  1 0/181 (0.00%)  0
Investigations           
Blood pressure increased †  0/185 (0.00%)  0 1/188 (0.53%)  1 0/184 (0.00%)  0 0/179 (0.00%)  0 0/181 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Hepatic cancer metastatic †  0/185 (0.00%)  0 1/188 (0.53%)  1 0/184 (0.00%)  0 0/179 (0.00%)  0 0/181 (0.00%)  0
Rectal cancer †  0/185 (0.00%)  0 1/188 (0.53%)  1 0/184 (0.00%)  0 0/179 (0.00%)  0 0/181 (0.00%)  0
Nervous system disorders           
Syncope †  0/185 (0.00%)  0 0/188 (0.00%)  0 0/184 (0.00%)  0 0/179 (0.00%)  0 1/181 (0.55%)  1
Renal and urinary disorders           
Nephrolithiasis †  0/185 (0.00%)  0 0/188 (0.00%)  0 0/184 (0.00%)  0 0/179 (0.00%)  0 1/181 (0.55%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride 0.02 mg Dutasteride 0.1 mg Dutasteride 0.5 mg Finasteride 1 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/185 (18.38%)      34/188 (18.09%)      41/184 (22.28%)      32/179 (17.88%)      36/181 (19.89%)    
Infections and infestations           
Nasopharyngitis †  19/185 (10.27%)  15/188 (7.98%)  23/184 (12.50%)  14/179 (7.82%)  16/181 (8.84%) 
Nervous system disorders           
Headache †  8/185 (4.32%)  8/188 (4.26%)  11/184 (5.98%)  5/179 (2.79%)  16/181 (8.84%) 
Psychiatric disorders           
Libido decreased †  10/185 (5.41%)  9/188 (4.79%)  6/184 (3.26%)  9/179 (5.03%)  2/181 (1.10%) 
Reproductive system and breast disorders           
Erectile dysfunction †  8/185 (4.32%)  7/188 (3.72%)  10/184 (5.43%)  10/179 (5.59%)  7/181 (3.87%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01231607    
Other Study ID Numbers: 114263
First Submitted: October 28, 2010
First Posted: November 1, 2010
Results First Submitted: August 30, 2012
Results First Posted: October 4, 2012
Last Update Posted: August 10, 2018