Trial Outcomes & Findings for Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia (NCT NCT01231607)
NCT ID: NCT01231607
Last Updated: 2018-08-10
Results Overview
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.
COMPLETED
PHASE3
917 participants
Baseline and Week 24
2018-08-10
Participant Flow
Participant milestones
| Measure |
Dutasteride 0.02 mg
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
|
Dutasteride 0.1 mg
Dutasteride 0.1 mg and finasteride placebo once daily
|
Dutasteride 0.5 mg
Dutasteride 0.5 mg and finasteride placebo once daily
|
Finasteride 1 mg
Finasteride 1 mg and dutasteride placebo once daily
|
Placebo
Matching dutasteride placebo and finasteride placebo once daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
185
|
188
|
184
|
179
|
181
|
|
Overall Study
COMPLETED
|
156
|
154
|
153
|
141
|
157
|
|
Overall Study
NOT COMPLETED
|
29
|
34
|
31
|
38
|
24
|
Reasons for withdrawal
| Measure |
Dutasteride 0.02 mg
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
|
Dutasteride 0.1 mg
Dutasteride 0.1 mg and finasteride placebo once daily
|
Dutasteride 0.5 mg
Dutasteride 0.5 mg and finasteride placebo once daily
|
Finasteride 1 mg
Finasteride 1 mg and dutasteride placebo once daily
|
Placebo
Matching dutasteride placebo and finasteride placebo once daily
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
8
|
4
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
13
|
11
|
10
|
10
|
4
|
|
Overall Study
Physician Decision
|
4
|
4
|
3
|
5
|
4
|
|
Overall Study
Protocol Violation
|
3
|
2
|
0
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
14
|
17
|
9
|
Baseline Characteristics
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Baseline characteristics by cohort
| Measure |
Dutasteride 0.02 mg
n=185 Participants
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
|
Dutasteride 0.1 mg
n=188 Participants
Dutasteride 0.1 mg and finasteride placebo once daily
|
Dutasteride 0.5 mg
n=184 Participants
Dutasteride 0.5 mg and finasteride placebo once daily
|
Finasteride 1 mg
n=179 Participants
Finasteride 1 mg and dutasteride placebo once daily
|
Placebo
n=181 Participants
Matching dutasteride placebo and finasteride placebo once daily
|
Total
n=917 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.5 Years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
38.7 Years
STANDARD_DEVIATION 7.44 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
38.0 Years
STANDARD_DEVIATION 7.81 • n=4 Participants
|
38.7 Years
STANDARD_DEVIATION 8.43 • n=21 Participants
|
38.5 Years
STANDARD_DEVIATION 7.80 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
917 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
199 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
188 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
211 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
96 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian - Mixed Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
220 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=148 Participants
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 mg
n=155 Participants
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
n=158 Participants
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
n=150 Participants
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
n=141 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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)
|
-4.9 Hair count
Standard Error 7.89
|
17.1 Hair count
Standard Error 7.74
|
63.0 Hair count
Standard Error 7.67
|
89.6 Hair count
Standard Error 7.87
|
56.5 Hair count
Standard Error 8.12
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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 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.
Outcome measures
| Measure |
Placebo
n=152 Participants
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 mg
n=158 Participants
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
n=159 Participants
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
n=152 Participants
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
n=142 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
|
-0.3 Hair count
Standard Error 1.74
|
4.2 Hair count
Standard Error 1.71
|
12.4 Hair count
Standard Error 1.70
|
18.1 Hair count
Standard Error 1.74
|
12.1 Hair count
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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 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.
Outcome measures
| Measure |
Placebo
n=147 Participants
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 mg
n=144 Participants
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
n=151 Participants
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
n=145 Participants
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
n=131 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
|
-4.0 Hair count
Standard Error 7.22
|
22.9 Hair count
Standard Error 7.32
|
59.6 Hair count
Standard Error 7.15
|
82.3 Hair count
Standard Error 7.29
|
50.9 Hair count
Standard Error 7.67
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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 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.
Outcome measures
| Measure |
Placebo
n=152 Participants
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 mg
n=154 Participants
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
n=155 Participants
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
n=149 Participants
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
n=134 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
|
-0.4 Hair count
Standard Error 1.63
|
5.1 Hair count
Standard Error 1.63
|
12.8 Hair count
Standard Error 1.62
|
17.1 Hair count
Standard Error 1.65
|
10.8 Hair count
Standard Error 1.74
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=148 Participants
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 mg
n=155 Participants
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
n=158 Participants
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
n=150 Participants
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
n=141 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
Week 12, n=147, 144, 151, 145, 131
|
-0.7 millimeters
Standard Error 0.40
|
0.3 millimeters
Standard Error 0.41
|
3.1 millimeters
Standard Error 0.40
|
4.7 millimeters
Standard Error 0.41
|
3.2 millimeters
Standard Error 0.43
|
|
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
Week 24, n=148, 155, 158, 150, 141
|
-0.9 millimeters
Standard Error 0.45
|
-0.0 millimeters
Standard Error 0.44
|
3.9 millimeters
Standard Error 0.44
|
5.8 millimeters
Standard Error 0.45
|
4.0 millimeters
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=152 Participants
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 mg
n=158 Participants
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
n=159 Participants
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
n=152 Participants
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
n=142 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
Week 12, n=152, 154, 155, 149, 134
|
-0.1 millimeters
Standard Error 0.09
|
0.1 millimeters
Standard Error 0.09
|
0.7 millimeters
Standard Error 0.09
|
0.9 millimeters
Standard Error 0.09
|
0.6 millimeters
Standard Error 0.10
|
|
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
Week 24, n=152, 158, 159, 152, 142
|
-0.2 millimeters
Standard Error 0.10
|
0.1 millimeters
Standard Error 0.10
|
0.8 millimeters
Standard Error 0.10
|
1.2 millimeters
Standard Error 0.10
|
0.8 millimeters
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=148 Participants
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 mg
n=155 Participants
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
n=158 Participants
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
n=150 Participants
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
n=141 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
Week 12, n=147, 144, 151, 145, 131
|
-11.5 Hair count
Standard Error 4.39
|
-13.4 Hair count
Standard Error 4.44
|
18.3 Hair count
Standard Error 4.35
|
29.3 Hair count
Standard Error 4.43
|
24.2 Hair count
Standard Error 4.67
|
|
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
Week 24, n=148, 155, 158, 150, 141
|
-17.5 Hair count
Standard Error 5.13
|
-15.7 Hair count
Standard Error 5.03
|
29.4 Hair count
Standard Error 4.99
|
46 Hair count
Standard Error 5.11
|
36.3 Hair count
Standard Error 5.28
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=152 Participants
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 mg
n=158 Participants
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
n=159 Participants
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
n=152 Participants
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
n=142 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
Week 12, n=152, 154, 155, 149, 134
|
-1.1 Hair count
Standard Error 1.05
|
-2.7 Hair count
Standard Error 1.05
|
4.0 Hair count
Standard Error 1.05
|
5.9 Hair count
Standard Error 1.06
|
4.5 Hair count
Standard Error 1.12
|
|
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
Week 24, n=152, 158, 159, 152, 142
|
-3.0 Hair count
Standard Error 1.20
|
-2.8 Hair count
Standard Error 1.18
|
6.0 Hair count
Standard Error 1.18
|
9.3 Hair count
Standard Error 1.20
|
7.2 Hair count
Standard Error 1.25
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=172 Participants
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 mg
n=174 Participants
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
n=176 Participants
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
n=167 Participants
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
n=165 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately
Vertex view, n=172, 174, 176, 167, 164
|
-0.15 scores on a scale
Standard Error 0.056
|
-0.09 scores on a scale
Standard Error 0.056
|
0.42 scores on a scale
Standard Error 0.055
|
0.63 scores on a scale
Standard Error 0.057
|
0.49 scores on a scale
Standard Error 0.057
|
|
Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately
Frontal/Superior view, n=171, 174, 176, 167, 165
|
-0.14 scores on a scale
Standard Error 0.054
|
-0.10 scores on a scale
Standard Error 0.053
|
0.36 scores on a scale
Standard Error 0.053
|
0.58 scores on a scale
Standard Error 0.055
|
0.34 scores on a scale
Standard Error 0.055
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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 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.
Outcome measures
| Measure |
Placebo
n=172 Participants
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 mg
n=171 Participants
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
n=172 Participants
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
n=166 Participants
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
n=160 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately
Vertex view
|
0.48 scores on a scale
Standard Error 0.068
|
0.35 scores on a scale
Standard Error 0.069
|
0.62 scores on a scale
Standard Error 0.068
|
0.78 scores on a scale
Standard Error 0.070
|
0.70 scores on a scale
Standard Error 0.071
|
|
Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately
Frontal view
|
0.30 scores on a scale
Standard Error 0.059
|
0.33 scores on a scale
Standard Error 0.059
|
0.54 scores on a scale
Standard Error 0.059
|
0.55 scores on a scale
Standard Error 0.060
|
0.55 scores on a scale
Standard Error 0.061
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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 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.
Outcome measures
| Measure |
Placebo
n=173 Participants
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 mg
n=174 Participants
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
n=177 Participants
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
n=167 Participants
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
n=165 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately
Vertex view
|
0.36 scores on a scale
Standard Error 0.079
|
0.37 scores on a scale
Standard Error 0.079
|
1.03 scores on a scale
Standard Error 0.078
|
1.30 scores on a scale
Standard Error 0.080
|
1.07 scores on a scale
Standard Error 0.081
|
|
Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately
Frontal view
|
0.30 scores on a scale
Standard Error 0.075
|
0.28 scores on a scale
Standard Error 0.075
|
0.78 scores on a scale
Standard Error 0.074
|
1.11 scores on a scale
Standard Error 0.076
|
0.88 scores on a scale
Standard Error 0.077
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=172 Participants
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 mg
n=177 Participants
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
n=173 Participants
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
n=169 Participants
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
n=161 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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)
BL S IIIv to W12 S II, n=79, 70, 69, 72, 73
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S IIa, n=79, 70, 69, 72, 73
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S III, n=79, 70, 69, 72, 73
|
4 participants
|
8 participants
|
11 participants
|
10 participants
|
11 participants
|
|
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)
BL S IIIv to W12 S IIIa, n=79, 70, 69, 72, 73
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S IIIv, n=79, 70, 69, 72, 73
|
71 participants
|
59 participants
|
55 participants
|
59 participants
|
62 participants
|
|
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)
BL S IIIv to W12 S IV, n=79, 70, 69, 72, 73
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S IVa, n=79, 70, 69, 72, 73
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S V, n=79, 70, 69, 72, 73
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S Va, n=79, 70, 69, 72, 73
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IIIv to W12 S VI, n=79, 70, 69, 72, 73
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IV to W12 S II, n=52, 59, 58, 56, 53
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IV to W12 S IIa, n=52, 59, 58, 56, 53
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IV to W12 S III, n=52, 59, 58, 56, 53
|
2 participants
|
4 participants
|
1 participants
|
4 participants
|
1 participants
|
|
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)
BL S IV to W12 S IIIa, n=52, 59, 58, 56, 53
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IV to W12 S IIIv, n=52, 59, 58, 56, 53
|
2 participants
|
3 participants
|
8 participants
|
5 participants
|
5 participants
|
|
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)
BL S IV to W12 S IV, n=52, 59, 58, 56, 53
|
45 participants
|
50 participants
|
44 participants
|
47 participants
|
45 participants
|
|
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)
BL S IV to W12 S IVa, n=52, 59, 58, 56, 53
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
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)
BL S IV to W12 S V, n=52, 59, 58, 56, 53
|
2 participants
|
2 participants
|
4 participants
|
0 participants
|
2 participants
|
|
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)
BL S IV to W12 S Va, n=52, 59, 58, 56, 53
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S IV to W12 S VI, n=52, 59, 58, 56, 53
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S V to W12 S II, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S V to W12 S IIa, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S V to W12 S III, n=41, 46, 46, 41, 35
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
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)
BL S V to W12 S IIIa, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S V to W12 S IIIv, n=41, 46, 46, 41, 35
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
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)
BL S V to W12 S IV, n=41, 46, 46, 41, 35
|
4 participants
|
4 participants
|
5 participants
|
5 participants
|
2 participants
|
|
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)
BL S V to W12 S IVa, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S V to W12 S V, n=41, 46, 46, 41, 35
|
35 participants
|
40 participants
|
38 participants
|
33 participants
|
33 participants
|
|
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)
BL S V to W12 S Va, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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)
BL S V to W12 S VI, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=173 Participants
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 mg
n=177 Participants
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
n=177 Participants
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
n=169 Participants
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
n=165 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
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
BL S V to W24 S III, n=41, 46, 46, 41, 35
|
2 participants
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
|
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
BL S IIIv to W24 S II, n=80, 72, 72, 72, 76
|
3 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
|
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
BL S IIIv to W24 S IIa, n=80, 72, 72, 72, 76
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
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
BL S IIIv to W24 S III, n=80, 72, 72, 72, 76
|
6 participants
|
8 participants
|
11 participants
|
13 participants
|
13 participants
|
|
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
BL S IIIv to W24 S IIIa, n=80, 72, 72, 72, 76
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IIIv to W24 S IIIv, n=80, 72, 72, 72, 76
|
67 participants
|
61 participants
|
58 participants
|
54 participants
|
59 participants
|
|
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
BL S IIIv to W24 S IV, n=80, 72, 72, 72, 76
|
4 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
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
BL S IIIv to W24 S IVa, n=80, 72, 72, 72, 76
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IIIv to W24 S V, n=80, 72, 72, 72, 76
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IIIv to W24 S Va, n=80, 72, 72, 72, 76
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IIIv to W24 S VI, n=80, 72, 72, 72, 76
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IV to W24 S II, n=52, 59, 59, 56, 54
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
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
BL S IV to W24 S IIa, n=52, 59, 59, 56, 54
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IV to W24 S III, n=52, 59, 59, 56, 54
|
2 participants
|
3 participants
|
4 participants
|
5 participants
|
4 participants
|
|
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
BL S IV to W24 S IIIa, n=52, 59, 59, 56, 54
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
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
BL S IV to W24 S IIIv, n=52, 59, 59, 56, 54
|
4 participants
|
7 participants
|
11 participants
|
10 participants
|
13 participants
|
|
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
BL S IV to W24 S IV, n=52, 59, 59, 56, 54
|
44 participants
|
46 participants
|
39 participants
|
37 participants
|
36 participants
|
|
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
BL S IV to W24 S IVa, n=52, 59, 59, 56, 54
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
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
BL S IV to W24 S V, n=52, 59, 59, 56, 54
|
2 participants
|
2 participants
|
4 participants
|
0 participants
|
1 participants
|
|
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
BL S IV to W24 S Va, n=52, 59, 59, 56, 54
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S IV to W24 S VI, n=52, 59, 59, 56, 54
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S V to W24 S II, n=41, 46, 46, 41, 35
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S V to W12 S IIa, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S V to W24 S Va, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S V to W24 S VI, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S V to W24 S IIIa, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
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
BL S V to W24 S IIIv, n=41, 46, 46, 41, 35
|
3 participants
|
1 participants
|
4 participants
|
3 participants
|
1 participants
|
|
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
BL S V to W24 S IV, n=41, 46, 46, 41, 35
|
7 participants
|
10 participants
|
8 participants
|
10 participants
|
8 participants
|
|
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
BL S V to W24 S IVa, n=41, 46, 46, 41, 35
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
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
BL S V to W24 S V, n=41, 46, 46, 41, 35
|
29 participants
|
33 participants
|
33 participants
|
25 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24, and Week 26Population: ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.
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).
Outcome measures
| Measure |
Placebo
n=172 Participants
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 mg
n=172 Participants
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
n=165 Participants
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
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
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)
Week 12, n=172, 172, 165
|
0.2 nanograms per milliliter (ng/mL)
Standard Deviation 1.96
|
2.1 nanograms per milliliter (ng/mL)
Standard Deviation 1.72
|
33.2 nanograms per milliliter (ng/mL)
Standard Deviation 20.10
|
—
|
—
|
|
Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)
Week 24, n=158, 158, 153
|
0.0 nanograms per milliliter (ng/mL)
Standard Deviation 0.14
|
2.0 nanograms per milliliter (ng/mL)
Standard Deviation 1.90
|
36.1 nanograms per milliliter (ng/mL)
Standard Deviation 23.21
|
—
|
—
|
|
Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)
Week 26, n=156, 154, 152
|
0.1 nanograms per milliliter (ng/mL)
Standard Deviation 0.84
|
0.3 nanograms per milliliter (ng/mL)
Standard Deviation 0.69
|
21.1 nanograms per milliliter (ng/mL)
Standard Deviation 17.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, Week 24, and Week 26Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=173 Participants
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 mg
n=177 Participants
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
n=177 Participants
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
n=171 Participants
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
n=165 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)
Week 26, n=173, 177, 177, 171, 165
|
1.21 nanomoles per liter (nmol/L)
Standard Deviation 0.523
|
1.11 nanomoles per liter (nmol/L)
Standard Deviation 0.600
|
0.77 nanomoles per liter (nmol/L)
Standard Deviation 0.602
|
0.37 nanomoles per liter (nmol/L)
Standard Deviation 0.451
|
1.03 nanomoles per liter (nmol/L)
Standard Deviation 0.636
|
|
Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)
Week 12, n=172, 174, 172, 170, 161
|
1.17 nanomoles per liter (nmol/L)
Standard Deviation 0.531
|
0.88 nanomoles per liter (nmol/L)
Standard Deviation 0.519
|
0.39 nanomoles per liter (nmol/L)
Standard Deviation 0.402
|
0.31 nanomoles per liter (nmol/L)
Standard Deviation 0.374
|
0.45 nanomoles per liter (nmol/L)
Standard Deviation 0.462
|
|
Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)
Week 24, n=173, 177, 176, 170, 165
|
1.16 nanomoles per liter (nmol/L)
Standard Deviation 0.482
|
1.01 nanomoles per liter (nmol/L)
Standard Deviation 0.540
|
0.49 nanomoles per liter (nmol/L)
Standard Deviation 0.500
|
0.31 nanomoles per liter (nmol/L)
Standard Deviation 0.402
|
0.49 nanomoles per liter (nmol/L)
Standard Deviation 0.500
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=172 Participants
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 mg
n=174 Participants
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
n=177 Participants
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
n=167 Participants
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
n=165 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24
Week 12, n=171, 171, 172, 166, 160
|
1.2 scores on a scale
Standard Error 0.19
|
0.9 scores on a scale
Standard Error 0.19
|
1.7 scores on a scale
Standard Error 0.19
|
2.0 scores on a scale
Standard Error 0.19
|
1.7 scores on a scale
Standard Error 0.20
|
|
Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24
Week 24, n=172, 174, 177, 167, 165
|
1.1 scores on a scale
Standard Error 0.22
|
1.1 scores on a scale
Standard Error 0.22
|
2.8 scores on a scale
Standard Error 0.22
|
3.2 scores on a scale
Standard Error 0.22
|
2.5 scores on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=172 Participants
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 mg
n=176 Participants
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
n=177 Participants
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
n=170 Participants
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
n=165 Participants
Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24
Week 12, n=171, 174, 173, 170, 160
|
8.5 scores on a scale
Standard Error 0.54
|
7.9 scores on a scale
Standard Error 0.53
|
9.8 scores on a scale
Standard Error 0.53
|
8.4 scores on a scale
Standard Error 0.54
|
8.5 scores on a scale
Standard Error 0.55
|
|
Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24
Week 24, n=172, 176, 177, 170, 165
|
9.3 scores on a scale
Standard Error 0.56
|
8.3 scores on a scale
Standard Error 0.56
|
11.5 scores on a scale
Standard Error 0.56
|
12.5 scores on a scale
Standard Error 0.56
|
10.8 scores on a scale
Standard Error 0.59
|
Adverse Events
Dutasteride 0.02 mg
Dutasteride 0.1 mg
Dutasteride 0.5 mg
Finasteride 1 mg
Placebo
Serious adverse events
| Measure |
Dutasteride 0.02 mg
n=185 participants at risk
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
|
Dutasteride 0.1 mg
n=188 participants at risk
Dutasteride 0.1 mg and finasteride placebo once daily
|
Dutasteride 0.5 mg
n=184 participants at risk
Dutasteride 0.5 mg and finasteride placebo once daily
|
Finasteride 1 mg
n=179 participants at risk
Finasteride 1 mg and dutasteride placebo once daily
|
Placebo
n=181 participants at risk
Matching dutasteride placebo and finasteride placebo once daily
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/185
|
0.53%
1/188 • Number of events 1
|
0.00%
0/184
|
0.00%
0/179
|
0.00%
0/181
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/185
|
0.00%
0/188
|
0.54%
1/184 • Number of events 1
|
0.00%
0/179
|
0.00%
0/181
|
|
Nervous system disorders
Syncope
|
0.00%
0/185
|
0.00%
0/188
|
0.00%
0/184
|
0.00%
0/179
|
0.55%
1/181 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/185
|
0.53%
1/188 • Number of events 1
|
0.00%
0/184
|
0.00%
0/179
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/185
|
0.53%
1/188 • Number of events 1
|
0.00%
0/184
|
0.00%
0/179
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/185
|
0.00%
0/188
|
0.00%
0/184
|
0.56%
1/179 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/185
|
0.00%
0/188
|
0.54%
1/184 • Number of events 1
|
0.00%
0/179
|
0.00%
0/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/185
|
0.53%
1/188 • Number of events 1
|
0.00%
0/184
|
0.00%
0/179
|
0.00%
0/181
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/185
|
0.00%
0/188
|
0.54%
1/184 • Number of events 1
|
0.00%
0/179
|
0.00%
0/181
|
|
Infections and infestations
Laryngitis
|
0.00%
0/185
|
0.00%
0/188
|
0.00%
0/184
|
0.56%
1/179 • Number of events 1
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/185
|
0.00%
0/188
|
0.00%
0/184
|
0.56%
1/179 • Number of events 1
|
0.00%
0/181
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/185
|
0.00%
0/188
|
0.00%
0/184
|
0.00%
0/179
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/185
|
0.00%
0/188
|
0.00%
0/184
|
0.56%
1/179 • Number of events 1
|
0.00%
0/181
|
Other adverse events
| Measure |
Dutasteride 0.02 mg
n=185 participants at risk
Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
|
Dutasteride 0.1 mg
n=188 participants at risk
Dutasteride 0.1 mg and finasteride placebo once daily
|
Dutasteride 0.5 mg
n=184 participants at risk
Dutasteride 0.5 mg and finasteride placebo once daily
|
Finasteride 1 mg
n=179 participants at risk
Finasteride 1 mg and dutasteride placebo once daily
|
Placebo
n=181 participants at risk
Matching dutasteride placebo and finasteride placebo once daily
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.3%
8/185
|
3.7%
7/188
|
5.4%
10/184
|
5.6%
10/179
|
3.9%
7/181
|
|
Nervous system disorders
Headache
|
4.3%
8/185
|
4.3%
8/188
|
6.0%
11/184
|
2.8%
5/179
|
8.8%
16/181
|
|
Psychiatric disorders
Libido decreased
|
5.4%
10/185
|
4.8%
9/188
|
3.3%
6/184
|
5.0%
9/179
|
1.1%
2/181
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
19/185
|
8.0%
15/188
|
12.5%
23/184
|
7.8%
14/179
|
8.8%
16/181
|
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