Trial Outcomes & Findings for A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia (NCT NCT00441116)

Results Overview

The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

153 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2018-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Dutasteride Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo Subjects who were given no Investigational product.
Overall Study STARTED	76	77
Overall Study COMPLETED	73	75
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dutasteride Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo Subjects who were given no Investigational product.
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Did not meet Eligibility Criteria	1	1

Baseline Characteristics

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dutasteride n=76 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=77 Participants Subjects who were given no Investigational product.	Total n=153 Participants Total of all reporting groups
Age, Continuous	37.78 years STANDARD_DEVIATION 7.07 • n=5 Participants	38.41 years STANDARD_DEVIATION 6.61 • n=7 Participants	38.097 years STANDARD_DEVIATION 6.84 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	77 Participants n=7 Participants	153 Participants n=5 Participants
Region of Enrollment Korea, Democratic People's Republic of	76 participants n=5 Participants	77 participants n=7 Participants	153 participants 0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. Baseline	148.14 hair count per centimeters squared Standard Deviation 36.27	144.27 hair count per centimeters squared Standard Deviation 32.33
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. Month 6	162.27 hair count per centimeters squared Standard Deviation 38.52	149.57 hair count per centimeters squared Standard Deviation 34.44
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. Change from Baseline - Month 6	12.21 hair count per centimeters squared Standard Deviation 23.60	4.67 hair count per centimeters squared Standard Deviation 16.81

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. Baseline	148.14 hair count per centimeters squared Standard Deviation 36.27	144.27 hair count per centimeters squared Standard Deviation 32.33
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. Month 3	160.19 hair count per centimeters squared Standard Deviation 36.73	154.50 hair count per centimeters squared Standard Deviation 36.87
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. Change from Baseline - Month 3	7.58 hair count per centimeters squared Standard Deviation 22.70	10.24 hair count per centimeters squared Standard Deviation 19.02

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Much less hair (Month 3)	5 Participants	4 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Moderately less hair (Month 3)	8 Participants	7 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Moderately more hair (Month 3)	1 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Much more hair (Month 3)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Much less hair (Month 6)	9 Participants	7 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Moderately less hair (Month 6)	13 Participants	8 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Slightly less hair (Month 6)	24 Participants	22 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? The same amount of hair (Month 6)	25 Participants	35 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Slightly more hair (Month 6)	2 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Moderately more hair (Month 6)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Much more hair (Month 6)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Slightly less hair (Month 3)	26 Participants	26 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? The same amount of hair (Month 3)	32 Participants	36 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? Slightly more hair (Month 3)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I strongly disagree (month 3)	0 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I disagree (month 3)	18 Participants	30 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? No opinion either way (month 3)	20 Participants	13 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I agree (month 3)	34 Participants	30 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I strongly agree (month 3)	1 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I strongly disagree (month 6)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I disagree (month 6)	18 Participants	27 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? No opinion either way (month 6)	12 Participants	17 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I agree (month 6)	40 Participants	29 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? I strongly agree (month 6)	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Moderately Better (Month 3)	7 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Much Better (Month 3)	4 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Much worse (Month 6)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Moderately worse (Month 6)	1 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Slightly worse (Month 6)	2 Participants	10 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Not changed (Month 6)	23 Participants	33 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Slightly Better (Month 6)	26 Participants	29 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Moderately Better (Month 6)	11 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Much Better (Month 6)	10 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Much worse (Month 3)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Moderately worse (Month 3)	0 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Slightly worse (Month 3)	1 Participants	4 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Not Changed (Month 3)	36 Participants	47 Participants
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? Slightly Better (Month 3)	25 Participants	20 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I strongly disagree (Month 3)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I disagree (Month 3)	4 Participants	8 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? No opinion either way (Month 3)	5 Participants	11 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I agree(Month 3)	62 Participants	56 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I strongly agree (Month 3)	2 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I strongly disagree (Month 6)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I disagree (Month 6)	3 Participants	8 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? No opinion either way (Month 6)	3 Participants	9 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I agree (Month 6)	60 Participants	58 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? I strongly agree(Month 6)	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Slightly more scalp (month 3)	3 Participants	14 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Moderately more scalp (month 3)	1 Participants	4 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Slightly less scalp (month 6)	26 Participants	15 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Much less scalp (month 3)	10 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Moderately less scalp (month 3)	17 Participants	11 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Slightly less scalp (month 3)	25 Participants	17 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? The same amount of scalp (month 3)	14 Participants	26 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Much more scalp (month 3)	3 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Much less scalp (month 6)	9 Participants	2 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Moderately less scalp (month 6)	16 Participants	5 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? The same amount of scalp (month 6)	20 Participants	26 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Slightly more scalp (month 6)	1 Participants	22 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Moderately more scalp (month 6)	1 Participants	4 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? Much more scalp (month 6)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Much less scalp (Month 3)	1 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Moderately less scalp (Month 3)	2 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Slightly less scalp (Month 3)	3 Participants	14 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? The same amount of scalp (Month 3)	20 Participants	24 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Slightly more scalp (Month 3)	25 Participants	23 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Moderately more scalp (Month 3)	15 Participants	7 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Much more scalp (Month 3)	7 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Much less scalp (Month 6)	0 Participants	2 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Moderately less scalp (Month 6)	0 Participants	5 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Slightly less scalp (Month 6)	2 Participants	21 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? The same amount of scalp (Month 6)	22 Participants	28 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Slightly more scalp (Month 6)	17 Participants	17 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Moderately more scalp (Month 6)	28 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? Much more scalp (Month 6)	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Greatly decreased (Month 3)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Moderately decreased (Month 3)	2 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Slightly decreased (Month 3)	7 Participants	19 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Stayed the same (Month 3)	17 Participants	21 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Slightly increased (Month 3)	26 Participants	21 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Moderately increased (Month 3)	15 Participants	10 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Greatly increased (Month 3)	6 Participants	3 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Greatly decreased (Month 6)	0 Participants	2 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Moderately decreased (Month 6)	0 Participants	4 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Slightly decreased (Month 6)	0 Participants	22 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Stayed the same (Month 6)	22 Participants	26 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Slightly increased (Month 6)	22 Participants	18 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Moderately increased (Month 6)	23 Participants	2 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? Greatly increased (Month 6)	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Much Worse (Month 3)	0 Participants	0 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Moderately Worse (Month 3)	2 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Slightly Worse (Month 3)	2 Participants	9 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Not Changed (Month 3)	16 Participants	28 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Slightly Better (Month 3)	28 Participants	24 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Moderately Better (Month 3)	14 Participants	9 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Much Better (Month 3)	11 Participants	4 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Much Worse (Month 6)	0 Participants	1 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Moderately Worse (Month 6)	0 Participants	2 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Slightly Worse (Month 6)	0 Participants	20 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Not Changed (Month 6)	21 Participants	25 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Slightly Better (Month 6)	24 Participants	23 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Moderately Better (Month 6)	19 Participants	2 Participants
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? Much Better (Month 6)	9 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Investigator's Photographic Assessment of Improvement Distribution From Baseline Greatly decreased (Month 3)	0 Participants	0 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Moderately decreased (Month 3)	1 Participants	1 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Slightly decreased (Month 3)	0 Participants	13 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline No Change (Month 3)	28 Participants	30 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Slightly increased (Month 3)	35 Participants	30 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Moderately increased (Month 3)	8 Participants	1 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Greatly increased (Month 3)	1 Participants	0 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Greatly decreased (Month 6)	0 Participants	0 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Moderately decreased (Month 6)	0 Participants	8 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Slightly decreased (Month 6)	4 Participants	16 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline No Change (Month 6)	24 Participants	36 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Slightly increased (Month 6)	31 Participants	14 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Moderately increased (Month 6)	12 Participants	1 Participants
Investigator's Photographic Assessment of Improvement Distribution From Baseline Greatly increased (Month 6)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.

Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.

Outcome measures

Outcome measures
Measure	Dutasteride n=64 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=67 Participants Subjects who were given no Investigational product.
Investigator's Photographic Assessment of Improvements From Baseline Score Month 3 Mean Score	0.78 units on a scale Standard Deviation 0.79	0.19 units on a scale Standard Deviation 0.78
Investigator's Photographic Assessment of Improvements From Baseline Score Month 6 Mean Score	0.88 units on a scale Standard Deviation 0.86	-0.30 units on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline to Month 3 and Baseline to Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Panel Assessment of Improvement Distribution From Screening Moderately increased (Month 6)	5 Participants	1 Participants
Panel Assessment of Improvement Distribution From Screening Greatly increased (Month 6)	2 Participants	0 Participants
Panel Assessment of Improvement Distribution From Screening Greatly decreased (Month 3)	0 Participants	0 Participants
Panel Assessment of Improvement Distribution From Screening Moderately decreased (Month 3)	1 Participants	0 Participants
Panel Assessment of Improvement Distribution From Screening Slightly decreased (Month 3)	3 Participants	14 Participants
Panel Assessment of Improvement Distribution From Screening No change (Month 3)	28 Participants	29 Participants
Panel Assessment of Improvement Distribution From Screening Slightly increased (Month 3)	33 Participants	28 Participants
Panel Assessment of Improvement Distribution From Screening Moderately increased (Month 3)	8 Participants	4 Participants
Panel Assessment of Improvement Distribution From Screening Greatly increased (Month 3)	0 Participants	0 Participants
Panel Assessment of Improvement Distribution From Screening Greatly decreased (Month 6)	0 Participants	1 Participants
Panel Assessment of Improvement Distribution From Screening Moderately decreased (Month 6)	0 Participants	4 Participants
Panel Assessment of Improvement Distribution From Screening Slightly decreased (Month 6)	6 Participants	29 Participants
Panel Assessment of Improvement Distribution From Screening No Change (Month 6)	40 Participants	32 Participants
Panel Assessment of Improvement Distribution From Screening Slightly increased (Month 6)	20 Participants	8 Participants

SECONDARY outcome

Timeframe: Month 3, Month 6 and Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 % Change in DHT - Month 3	-16.92 Percent change Standard Deviation 54.14	-1.90 Percent change Standard Deviation 47.58
The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 % Change in DHT - Month 6	-4.30 Percent change Standard Deviation 38.73	22.83 Percent change Standard Deviation 45.30
The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 % Change in DHT - Month 10	3.85 Percent change Standard Deviation 44.34	7.58 Percent change Standard Deviation 50.28

SECONDARY outcome

Timeframe: Month 3, Month 6, and Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.

Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 % Change in Testosterone - Month 3	18.78 Percent change Standard Deviation 28.69	-5.27 Percent change Standard Deviation 28.90
The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 % Change in Testosterone - Month 6	8.15 Percent change Standard Deviation 30.18	-6.59 Percent change Standard Deviation 31.86
The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 % Change in Testosterone - Month 10	12.18 Percent change Standard Deviation 26.17	0.99 Percent change Standard Deviation 27.42

SECONDARY outcome

Timeframe: Baseline to Month 6 and Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.

Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, \<0.1, adult, 0.25-0.75; females (f): prepuberty, \<0.03, premenopausal, 0.05-0.3, menopausal, \<0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, \>20; luteal 5-20; postmenopausal, \>10 IU/L.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. TSH - Baseline - Normal	70 Participants	75 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. TSH - Baseline - Abnormal	3 Participants	0 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. TSH - Month 6 - Normal	70 Participants	69 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. TSH - Month 6 - Abnormal	0 Participants	4 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. TSH - Month 10 - Normal	71 Participants	74 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. TSH - Month 10 - Abnormal	1 Participants	1 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. T4 - Baseline - Normal	73 Participants	75 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. T4 - Baseline - Abnormal	0 Participants	0 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. T4 - Month 6 - Normal	70 Participants	71 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. T4 - Month 6 - Abnormal	0 Participants	2 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. T4 - Month 10 - Normal	72 Participants	74 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. T4 - Month 10 - Abnormal	0 Participants	1 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. PSA - Screening - Normal	73 Participants	75 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. PSA - Screening - Abnormal	0 Participants	0 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. PSA - Month 6 - Normal	70 Participants	73 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. PSA - Month 6 - Abnormal	0 Participants	0 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. PSA - Month 10 - Normal	72 Participants	75 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. PSA - Month 10 - Abnormal	0 Participants	0 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. DHT - Screening - Normal	72 Participants	74 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. DHT - Screening - Abnormal	1 Participants	1 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. DHT - Month 6 - Normal	69 Participants	69 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. DHT - Month 6 - Abnormal	1 Participants	4 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. DHT - Month 10 - Normal	70 Participants	72 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. DHT - Month 10 - Abnormal	2 Participants	3 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. Testosterone - Screening - Normal	73 Participants	74 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. Testosterone - Screening - Abnormal	0 Participants	1 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. Testosterone - Month 6 - Normal	67 Participants	71 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. Testosterone - Month 6 - Abnormal	3 Participants	2 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. Testosterone - Month 10 - Normal	69 Participants	74 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. Testosterone - Month 10 - Abnormal	3 Participants	1 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. LH - Baseline - Normal	67 Participants	64 Participants
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. LH - Baseline - Abnormal	6 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

Sodium, Potassium (mEq/L), and Bicarbonate

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Sodium - Baseline	141.23 mmol/L Standard Deviation 1.72	141.41 mmol/L Standard Deviation 1.62
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Sodium - Month 6	141.54 mmol/L Standard Deviation 2.01	141.58 mmol/L Standard Deviation 1.65
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Potassium (mEq/L) - Baseline	4.22 mmol/L Standard Deviation 0.31	4.34 mmol/L Standard Deviation 0.33
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Potassium (mEq/L) - Month 6	4.25 mmol/L Standard Deviation 0.32	4.29 mmol/L Standard Deviation 0.26
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Bicarbonate - Baseline	27.66 mmol/L Standard Deviation 2.19	28.23 mmol/L Standard Deviation 2.28
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Bicarbonate - Month 6	26.61 mmol/L Standard Deviation 2.12	27.08 mmol/L Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

Comparing Lab values and differences from Baseline to month 6

Outcome measures

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. AST(SGOT) - Baseline	23.10 IU/L Standard Deviation 6.77	22.80 IU/L Standard Deviation 6.14
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. AST(SGOT) - Month 6	25.88 IU/L Standard Deviation 10.55	25.11 IU/L Standard Deviation 9.51
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. ALT(SGPT) - Baseline	29.79 IU/L Standard Deviation 15.11	26.91 IU/L Standard Deviation 12.36
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. ALT(SGPT) - Month 6	34.00 IU/L Standard Deviation 25.79	30.47 IU/L Standard Deviation 18.81
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. Alkaline Phosphatase - Baseline	87.34 IU/L Standard Deviation 40.14	85.79 IU/L Standard Deviation 46.15
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. Alkaline Phosphatase - Month 6	85.51 IU/L Standard Deviation 33.09	84.24 IU/L Standard Deviation 42.44
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. Bilirubin (mg/dL) - Baseline	0.78 IU/L Standard Deviation 0.32	0.71 IU/L Standard Deviation 0.28
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. Bilirubin (mg/dL) - Month 6	0.80 IU/L Standard Deviation 0.32	0.79 IU/L Standard Deviation 0.31
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. Albumin (g/dL) - Baseline	4.66 IU/L Standard Deviation 0.22	4.60 IU/L Standard Deviation 0.25
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. Albumin (g/dL) - Month 6	4.64 IU/L Standard Deviation 0.21	4.60 IU/L Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Glucose - Baseline	104.48 mg/dL Standard Deviation 25.32	101.56 mg/dL Standard Deviation 16.17
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Glucose - Month 6	104.49 mg/dL Standard Deviation 24.45	106.31 mg/dL Standard Deviation 20.82
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Creatinine - Baseline	1.03 mg/dL Standard Deviation 0.14	1.03 mg/dL Standard Deviation 0.14
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Creatinine - Month 6	1.05 mg/dL Standard Deviation 0.11	1.06 mg/dL Standard Deviation 0.14
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Ferritine (ug/L) - Baseline	100.21 mg/dL Standard Deviation 55.11	131.91 mg/dL Standard Deviation 77.74
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Ferritine (ug/L) - Month 6	109.61 mg/dL Standard Deviation 64.29	132.36 mg/dL Standard Deviation 87.91
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Zinc (Hmol/L) - Baseline	111.19 mg/dL Standard Deviation 35.35	112.66 mg/dL Standard Deviation 45.62
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Zinc (Hmol/L) - Month 6	118.07 mg/dL Standard Deviation 40.75	113.87 mg/dL Standard Deviation 39.80

SECONDARY outcome

Timeframe: Screening

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Sex Drive - Very Small Problem	5 Participants	5 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Sex Drive - Small Problem	4 Participants	9 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Sex Drive - Medium Problem	4 Participants	3 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Sex Drive - No Problem	60 Participants	58 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Sex Drive - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Erection - No Problem	62 Participants	60 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Erection - Very Small Problem	7 Participants	6 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Erection - Small Problem	4 Participants	7 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Erection - Medium Problem	0 Participants	2 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Erection - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Ejaculation - No Problem	64 Participants	63 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Ejaculation - Very Small Problem	6 Participants	4 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Ejaculation - Small Problem	3 Participants	7 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Ejaculation - Medium Problem	0 Participants	1 Participants
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation Ejaculation - Big Problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Sex Drive - No Problem	63 Participants	60 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Sex Drive - Very small problem	4 Participants	5 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Sex Drive - Small problem	6 Participants	8 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Sex Drive - Medium problem	0 Participants	1 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Sex Drive - Big problem	0 Participants	0 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Erection - No Problem	64 Participants	60 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Erection - Very small problem	5 Participants	6 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Erection - Small problem	4 Participants	7 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Erection - Medium problem	0 Participants	1 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Erection - Big problem	0 Participants	0 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Ejaculation - No Problem	63 Participants	62 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Ejaculation - Very small problem	7 Participants	5 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Ejaculation - Small problem	3 Participants	7 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Ejaculation - Medium problem	0 Participants	0 Participants
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation Ejaculation - Big problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 3

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Ejaculation - Very Small Problem	9 Participants	8 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Ejaculation - Small Problem	3 Participants	3 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Sex Drive - No Problem	49 Participants	59 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Sex Drive - Very small Problem	12 Participants	8 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Sex Drive - Small Problem	5 Participants	5 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Sex Drive - Medium Problem	5 Participants	0 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Sex Drive - Big Problem	0 Participants	1 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Erection - No Problem	52 Participants	56 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Erection - Very Small Problem	11 Participants	10 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Erection - Small Problem	2 Participants	3 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Erection - Medium Problem	6 Participants	3 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Erection - Big Problem	0 Participants	1 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Ejaculation - No Problem	55 Participants	59 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Ejaculation - Medium Problem	4 Participants	2 Participants
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation Ejaculation - Big Problem	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Sex Drive - Very Small Problem	7 Participants	6 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Ejaculation - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Erection - Very Small Problem	6 Participants	9 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Erection - No Problem	57 Participants	58 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Sex Drive - No Problem	56 Participants	59 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Sex Drive - Small Problem	7 Participants	8 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Sex Drive - Medium Problem	2 Participants	2 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Sex Drive - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Erection - Small Problem	6 Participants	7 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Erection - Medium Problem	3 Participants	1 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Erection - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Ejaculation - No Problem	58 Participants	59 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Ejaculation - Very Small Problem	8 Participants	8 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Ejaculation - Small Problem	4 Participants	6 Participants
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation Ejaculation - Medium Problem	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Ejaculation - Big Problem	1 Participants	0 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Ejaculation - Medium Problem	0 Participants	2 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Sex Drive - No Problem	62 Participants	62 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Sex Drive - Very Small Problem	7 Participants	6 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Sex Drive - Small Problem	2 Participants	4 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Sex Drive - Medium Problem	1 Participants	3 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Sex Drive - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Erection - No Problem	59 Participants	60 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Erection - Very Small Problem	9 Participants	11 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Erection - Small Problem	4 Participants	2 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Erection - Medium Problem	0 Participants	2 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Erection - Big Problem	0 Participants	0 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Ejaculation - No Problem	60 Participants	62 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Ejaculation - Very Small Problem	7 Participants	10 Participants
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation Ejaculation - Small Problem	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive No Problem shift to Small Problem	2 Participants	4 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive No Problem shift to No Problem	53 Participants	52 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive No Problem shift to Very Small Problem	6 Participants	4 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive No Problem shift to Medium Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive No Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Very Small Problem shift to No Problem	0 Participants	4 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Very Small Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Very Small Problem shift to Small Problem	3 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Very Small Problem shift to Medium Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Very Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Small Problem shift to No Problem	3 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Small Problem shift to Very Small Problem	1 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Small Problem shift to Small Problem	2 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Small Problem shift to Medium Problem	0 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Medium Problem shift to No Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Medium Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Medium Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Medium Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Medium Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Big Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Big Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Big Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Big Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive Big Problem shift to Big Problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection No Problem shift to No Problem	53 Participants	52 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection No Problem shift to Very Small Problem	6 Participants	5 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection No Problem shift to Small Problem	3 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection No Problem shift to Medium Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection No Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Very Small Problem shift to No Problem	2 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Very Small Problem shift to Very Small Problem	0 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Very Small Problem shift to Small Problem	2 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Very Small Problem shift to Medium Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Very Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Small Problem shift to No Problem	2 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Small Problem shift to Very Small Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Small Problem shift to Small Problem	1 Participants	4 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Small Problem shift to Medium Problem	1 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Medium Problem shift to No Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Medium Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Medium Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Medium Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Medium Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Big Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Big Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Big Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Big Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection Big Problem shift to Big Problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation No Problem shift to No Problem	54 Participants	54 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation No Problem shift to Very Small Problem	5 Participants	5 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation No Problem shift to Small Problem	2 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation No Problem shift to Medium Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation No Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Very Small Problem shift to No Problem	3 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Very Small Problem shift to Very Small Problem	3 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Very Small Problem shift to Small Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Very Small Problem shift to Medium Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Very Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Small Problem shift to No Problem	1 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Small Problem shift to Very Small Problem	0 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Small Problem shift to Small Problem	1 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Small Problem shift to Medium Problem	1 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Medium Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Medium Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Medium Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Medium Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Medium Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Big Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Big Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Big Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Big Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation Big Problem shift to Big Problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive No Problem shift to No Problem	57 Participants	55 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive No Problem shift to Very Small Problem	5 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive No Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive No Problem shift to Medium Problem	0 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive No Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Very Small Problem shift to No Problem	2 Participants	4 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Very Small Problem shift to Very Small Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Very Small Problem shift to Small Problem	1 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Very Small Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Very Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Small Problem shift to No Problem	3 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Small Problem shift to Very Small Problem	1 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Small Problem shift to Small Problem	1 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Small Problem shift to Medium Problem	1 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Medium Problem shift to No Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Medium Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Medium Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Medium Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Medium Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Big Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Big Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Big Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Big Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive Big Problem shift to Big Problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection No Problem shift to No Problem	54 Participants	54 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection No Problem shift to Very Small Problem	6 Participants	5 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection No Problem shift to Small Problem	3 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection No Problem shift to Medium Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection No Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Very Small Problem shift to No Problem	2 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Very Small Problem shift to Very Small Problem	3 Participants	4 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Very Small Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Very Small Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Very Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Small Problem shift to No Problem	3 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Small Problem shift to Very Small Problem	0 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Small Problem shift to Small Problem	1 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Small Problem shift to Medium Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Medium Problem shift to No Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Medium Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Medium Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Medium Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Medium Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Big Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Big Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Big Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Big Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection Big Problem shift to Big Problem	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Month 10

Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

Outcome measures

Outcome measures
Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation No Problem shift to No Problem	56 Participants	56 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation No Problem shift to Very Small problem	2 Participants	6 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation No Problem shift to Small Problem	3 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation No Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation No Problem shift to Big Problem	1 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Very Small Problem shift to No Problem	2 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Very Small Problem shift to Very Small Problem	5 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Very Small Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Very Small Problem shift to Medium Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Very Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Small Problem shift to No Problem	2 Participants	2 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Small Problem shift to Very Small Problem	0 Participants	3 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Small Problem shift to Small Problem	1 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Small Problem shift to Medium Problem	0 Participants	1 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Small Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Medium Problem shift to No Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Medium Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Medium Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Medium Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Medium Problem shift to Big Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Big Problem shift to No Proble	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Big Problem shift to Very Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Big Problem shift to Small Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Big Problem shift to Medium Problem	0 Participants	0 Participants
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation Big Problem shift to Big Problem	0 Participants	0 Participants

Adverse Events

Dutasteride

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dutasteride n=73 participants at risk Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 participants at risk Subjects who were given no Investigational product.
Endocrine disorders Thyroid Cancer	0.00% 0/73	1.3% 1/75 • Number of events 1

Other adverse events

Other adverse events
Measure	Dutasteride n=73 participants at risk Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 participants at risk Subjects who were given no Investigational product.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	16.4% 12/73	9.3% 7/75

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will no prohibit any investigator form 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

Measure	Dutasteride n=73 Participants Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.	Placebo n=75 Participants Subjects who were given no Investigational product.
Laboratory Values: Hematology Assessed at Baseline and 6 Months. WBC - Baseline	6898.49 thousands/microliter Standard Deviation 1991.34	6336.93 thousands/microliter Standard Deviation 1815.00
Laboratory Values: Hematology Assessed at Baseline and 6 Months. WBC - Month 6	6463.61 thousands/microliter Standard Deviation 1421.58	6387.03 thousands/microliter Standard Deviation 1828.81
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Neutrophils - Baseline	53.46 thousands/microliter Standard Deviation 9.17	53.52 thousands/microliter Standard Deviation 8.63
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Neutrophils - Month 6	52.47 thousands/microliter Standard Deviation 8.46	52.90 thousands/microliter Standard Deviation 8.51
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Lymphocytes - Baseline	35.96 thousands/microliter Standard Deviation 8.03	35.87 thousands/microliter Standard Deviation 8.28
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Lymphocytes - Month 6	36.96 thousands/microliter Standard Deviation 7.61	36.03 thousands/microliter Standard Deviation 8.19
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Monocytes - Baseline	7.03 thousands/microliter Standard Deviation 1.64	7.03 thousands/microliter Standard Deviation 1.80
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Monocytes - Month 6	7.08 thousands/microliter Standard Deviation 1.39	7.14 thousands/microliter Standard Deviation 1.75
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Eosinophils - Baseline	2.81 thousands/microliter Standard Deviation 2.34	2.69 thousands/microliter Standard Deviation 1.71
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Eosinophils - Month 6	2.75 thousands/microliter Standard Deviation 2.08	2.99 thousands/microliter Standard Deviation 2.21
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Basophils - Baseline	0.48 thousands/microliter Standard Deviation 0.28	0.52 thousands/microliter Standard Deviation 0.28
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Basophils - Month 6	0.50 thousands/microliter Standard Deviation 0.21	0.51 thousands/microliter Standard Deviation 0.26
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Platelets - Baseline	249.63 thousands/microliter Standard Deviation 52.79	250.19 thousands/microliter Standard Deviation 53.67
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Platelets - Month 6	243.69 thousands/microliter Standard Deviation 46.03	240.26 thousands/microliter Standard Deviation 50.90
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Hemoglobin (%)- Baseline	15.44 thousands/microliter Standard Deviation 1.17	15.54 thousands/microliter Standard Deviation 0.88
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Hemoglobin (%) - Month 6	15.41 thousands/microliter Standard Deviation 1.10	15.46 thousands/microliter Standard Deviation 0.86
Laboratory Values: Hematology Assessed at Baseline and 6 Months. MCV (fL)- Baseline	92.12 thousands/microliter Standard Deviation 3.31	91.89 thousands/microliter Standard Deviation 4.06
Laboratory Values: Hematology Assessed at Baseline and 6 Months. MCV (fL) - Month 6	91.57 thousands/microliter Standard Deviation 3.51	91.44 thousands/microliter Standard Deviation 3.88