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 - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Condition:	Androgenetic Alopecia
Intervention:	Drug: Dutasteride 0.5mg oral tablets

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

	Dutasteride	Placebo
STARTED	76	77
COMPLETED	73	75
NOT COMPLETED	3	2
Adverse Event	1	1
Withdrawal by Subject	1	0
Did not meet Eligibility Criteria	1	1

	Dutasteride	Placebo	Total
Number of Participants [units: participants]	76	77	153
Age [units: years] Mean ± Standard Deviation	37.78 ± 7.07	38.41 ± 6.61	38.097 ± 6.84
Gender [units: participants]
Female	0	0	0
Male	76	77	153
Region of Enrollment [units: participants]
Korea, Democratic People's Republic of	76	77	153

Outcome Measures

1. Primary:

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. [ Baseline and 6 months ]

Measure Type	Primary
Measure Title	Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
Measure Description	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.
Time Frame	Baseline and 6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. [units: hair count per centimeters squared] Mean ± Standard Deviation
Baseline	148.14 ± 36.27	144.27 ± 32.33
Month 6	162.27 ± 38.52	149.57 ± 34.44
Change from Baseline - Month 6	12.21 ± 23.60	4.67 ± 16.81

Statistical Analysis 1 for Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.0319
Median Difference (Final Values) ^[4]	7.54
Standard Deviation	± 20.37
95% Confidence Interval	( 0.75 to 14.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Month 6 - Baseline
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Mean difference = Drug A minus Drug B

2. Secondary:

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. [ Baseline and Month 3 ]

Measure Type	Secondary
Measure Title	Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
Measure Description	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.
Time Frame	Baseline and Month 3
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. [units: hair count per centimeters squared] Mean ± Standard Deviation
Baseline	148.14 ± 36.27	144.27 ± 32.33
Month 3	160.19 ± 36.73	154.50 ± 36.87
Change from Baseline - Month 3	7.58 ± 22.70	10.24 ± 19.02

No statistical analysis provided for Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.

3. Secondary:

Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? [units: Participants]
Much less hair (Month 3)	5	4
Moderately less hair (Month 3)	8	7
Slightly less hair (Month 3)	26	26
The same amount of hair (Month 3)	32	36
Slightly more hair (Month 3)	1	2
Moderately more hair (Month 3)	1	0
Much more hair (Month 3)	0	0
Much less hair (Month 6)	9	7
Moderately less hair (Month 6)	13	8
Slightly less hair (Month 6)	24	22
The same amount of hair (Month 6)	25	35
Slightly more hair (Month 6)	2	3
Moderately more hair (Month 6)	0	0
Much more hair (Month 6)	0	0

No statistical analysis provided for Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?

4. Secondary:

Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? [units: Participants]
I strongly disagree (month 3)	0	1
I disagree (month 3)	18	30
No opinion either way (month 3)	20	13
I agree (month 3)	34	30
I strongly agree (month 3)	1	1
I strongly disagree (month 6)	0	0
I disagree (month 6)	18	27
No opinion either way (month 6)	12	17
I agree (month 6)	40	29
I strongly agree (month 6)	3	2

No statistical analysis provided for Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?

5. Secondary:

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? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	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?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
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? [units: Participants]
Much worse (Month 3)	0	0
Moderately worse (Month 3)	0	1
Slightly worse (Month 3)	1	4
Not Changed (Month 3)	36	47
Slightly Better (Month 3)	25	20
Moderately Better (Month 3)	7	3
Much Better (Month 3)	4	0
Much worse (Month 6)	0	0
Moderately worse (Month 6)	1	0
Slightly worse (Month 6)	2	10
Not changed (Month 6)	23	33
Slightly Better (Month 6)	26	29
Moderately Better (Month 6)	11	3
Much Better (Month 6)	10	0

No statistical analysis provided for 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?

6. Secondary:

Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? [units: Participants]
I strongly disagree (Month 3)	0	0
I disagree (Month 3)	4	8
No opinion either way (Month 3)	5	11
I agree(Month 3)	62	56
I strongly agree (Month 3)	2	0
I strongly disagree (Month 3)	0	0
I disagree (Month 6)	3	8
No opinion either way (Month 6)	3	9
I agree (Month 6)	60	58
I strongly agree(Month 6)	7	0

No statistical analysis provided for Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?

7. Secondary:

Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? [units: Participants]
Much less scalp (month 3)	10	3
Moderately less scalp (month 3)	17	11
Slightly less scalp (month 3)	25	17
The same amount of scalp (month 3)	14	26
Slightly more scalp (month 3)	3	14
Moderately more scalp (month 3)	1	4
Much more scalp (month 3)	3	0
Much less scalp (month 6)	9	2
Moderately less scalp (month 6)	16	5
Slightly less scalp (month 6)	26	15
The same amount of scalp (month 6)	20	26
Slightly more scalp (month 6)	1	22
Moderately more scalp (month 6)	1	4
Much more scalp (month 6)	0	1

No statistical analysis provided for Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?

8. Secondary:

Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? [units: Participants]
Much less scalp (Month 3)	1	1
Moderately less scalp (Month 3)	2	3
Slightly less scalp (Month 3)	3	14
The same amount of scalp (Month 3)	20	24
Slightly more scalp (Month 3)	25	23
Moderately more scalp (Month 3)	15	7
Much more scalp (Month 3)	7	3
Much less scalp (Month 6)	0	2
Moderately less scalp (Month 6)	0	5
Slightly less scalp (Month 6)	2	21
The same amount of scalp (Month 6)	22	28
Slightly more scalp (Month 6)	17	17
Moderately more scalp (Month 6)	28	1
Much more scalp (Month 6)	4	1

No statistical analysis provided for Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?

9. Secondary:

Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? [units: Participants]
Greatly decreased (Month 3)	0	0
Moderately decreased (Month 3)	2	1
Slightly decreased (Month 3)	7	19
Stayed the same (Month 3)	17	21
Slightly increased (Month 3)	26	21
Moderately increased (Month 3)	15	10
Greatly increased (Month 3)	6	3
Greatly decreased (Month 6)	0	2
Moderately decreased (Month 6)	0	4
Slightly decreased (Month 6)	0	22
Stayed the same (Month 6)	22	26
Slightly increased (Month 6)	22	18
Moderately increased (Month 6)	23	2
Greatly increased (Month 6)	6	1

No statistical analysis provided for Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?

10. Secondary:

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? [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	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?
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
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? [units: Participants]
Much Worse (Month 3)	0	0
Moderately Worse (Month 3)	2	1
Slightly Worse (Month 3)	2	9
Not Changed (Month 3)	16	28
Slightly Better (Month 3)	28	24
Moderately Better (Month 3)	14	9
Much Better (Month 3)	11	4
Much Worse (Month 6)	0	1
Moderately Worse (Month 6)	0	2
Slightly Worse (Month 6)	0	20
Not Changed (Month 6)	21	25
Slightly Better (Month 6)	24	23
Moderately Better (Month 6)	19	2
Much Better (Month 6)	9	2

No statistical analysis provided for 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?

11. Secondary:

Investigator's Photographic Assessment of Improvement Distribution From Baseline [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Investigator's Photographic Assessment of Improvement Distribution From Baseline
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Investigator's Photographic Assessment of Improvement Distribution From Baseline [units: Participants]
Greatly decreased (Month 3)	0	0
Moderately decreased (Month 3)	1	1
Slightly decreased (Month 3)	0	13
No Change (Month 3)	28	30
Slightly increased (Month 3)	35	30
Moderately increased (Month 3)	8	1
Greatly increased (Month 3)	1	0
Greatly decreased (Month 6)	0	0
Moderately decreased (Month 6)	0	8
Slightly decreased (Month 6)	4	16
No Change (Month 6)	24	36
Slightly increased (Month 6)	31	14
Moderately increased (Month 6)	12	1
Greatly increased (Month 6)	2	0

No statistical analysis provided for Investigator's Photographic Assessment of Improvement Distribution From Baseline

12. Secondary:

Investigator's Photographic Assessment of Improvements From Baseline Score [ Month 3 and Month 6 ]

Measure Type	Secondary
Measure Title	Investigator's Photographic Assessment of Improvements From Baseline Score
Measure Description	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.
Time Frame	Month 3 and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	64	67
Investigator's Photographic Assessment of Improvements From Baseline Score [units: units on a scale] Mean ± Standard Deviation
Month 3 Mean Score	0.78 ± 0.79	0.19 ± 0.78
Month 6 Mean Score	0.88 ± 0.86	-0.30 ± 0.85

No statistical analysis provided for Investigator's Photographic Assessment of Improvements From Baseline Score

13. Secondary:

Panel Assessment of Improvement Distribution From Screening [ Baseline to Month 3 and Baseline to Month 6 ]

Measure Type	Secondary
Measure Title	Panel Assessment of Improvement Distribution From Screening
Measure Description	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.
Time Frame	Baseline to Month 3 and Baseline to Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Panel Assessment of Improvement Distribution From Screening [units: Participants]
Greatly decreased (Month 3)	0	0
Moderately decreased (Month 3)	1	0
Slightly decreased (Month 3)	3	14
No change (Month 3)	28	29
Slightly increased (Month 3)	33	28
Moderately increased (Month 3)	8	4
Greatly increased (Month 3)	0	0
Greatly decreased (Month 6)	0	1
Moderately decreased (Month 6)	0	4
Slightly decreased (Month 6)	6	29
No Change (Month 6)	40	32
Slightly increased (Month 6)	20	8
Moderately increased (Month 6)	5	1
Greatly increased (Month 6)	2	0

No statistical analysis provided for Panel Assessment of Improvement Distribution From Screening

14. Secondary:

The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 [ Month 3, Month 6 and Month 10 ]

Measure Type	Secondary
Measure Title	The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10
Measure Description	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.
Time Frame	Month 3, Month 6 and Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 [units: Percent change] Mean ± Standard Deviation
% Change in DHT - Month 3	-16.92 ± 54.14	-1.90 ± 47.58
% Change in DHT - Month 6	-4.30 ± 38.73	22.83 ± 45.30
% Change in DHT - Month 10	3.85 ± 44.34	7.58 ± 50.28

No statistical analysis provided for The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10

15. Secondary:

The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 [ Month 3, Month 6, and Month 10 ]

Measure Type	Secondary
Measure Title	The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10
Measure Description	Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.
Time Frame	Month 3, Month 6, and Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 [units: Percent change] Mean ± Standard Deviation
% Change in Testosterone - Month 3	18.78 ± 28.69	-5.27 ± 28.90
% Change in Testosterone - Month 6	8.15 ± 30.18	-6.59 ± 31.86
% Change in Testosterone - Month 10	12.18 ± 26.17	0.99 ± 27.42

No statistical analysis provided for The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10

16. Secondary:

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. [ Baseline to Month 6 and Month 10 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	Baseline to Month 6 and Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
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. [units: Participants]
TSH - Baseline - Normal	70	75
TSH - Baseline - Abnormal	3	0
TSH - Month 6 - Normal	70	69
TSH - Month 6 - Abnormal	0	4
TSH - Month 10 - Normal	71	74
TSH - Month 10 - Abnormal	1	1
T4 - Baseline - Normal	73	75
T4 - Baseline - Abnormal	0	0
T4 - Month 6 - Normal	70	71
T4 - Month 6 - Abnormal	0	2
T4 - Month 10 - Normal	72	74
T4 - Month 10 - Abnormal	0	1
PSA - Screening - Normal	73	75
PSA - Screening - Abnormal	0	0
PSA - Month 6 - Normal	70	73
PSA - Month 6 - Abnormal	0	0
PSA - Month 10 - Normal	72	75
PSA - Month 10 - Abnormal	0	0
DHT - Screening - Normal	72	74
DHT - Screening - Abnormal	1	1
DHT - Month 6 - Normal	69	69
DHT - Month 6 - Abnormal	1	4
DHT - Month 10 - Normal	70	72
DHT - Month 10 - Abnormal	2	3
Testosterone - Screening - Normal	73	74
Testosterone - Screening - Abnormal	0	1
Testosterone - Month 6 - Normal	67	71
Testosterone - Month 6 - Abnormal	3	2
Testosterone - Month 10 - Normal	69	74
Testosterone - Month 10 - Abnormal	3	1
LH - Baseline - Normal	67	64
LH - Baseline - Abnormal	6	11

No statistical analysis provided for 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.

17. Secondary:

Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. [ Baseline and Month 6 ]

Measure Type	Secondary
Measure Title	Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
Measure Description	Sodium, Potassium (mEq/L), and Bicarbonate
Time Frame	Baseline and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. [units: mmol/L] Mean ± Standard Deviation
Sodium - Baseline	141.23 ± 1.72	141.41 ± 1.62
Sodium - Month 6	141.54 ± 2.01	141.58 ± 1.65
Potassium (mEq/L) - Baseline	4.22 ± 0.31	4.34 ± 0.33
Potassium (mEq/L) - Month 6	4.25 ± 0.32	4.29 ± 0.26
Bicarbonate - Baseline	27.66 ± 2.19	28.23 ± 2.28
Bicarbonate - Month 6	26.61 ± 2.12	27.08 ± 2.30

No statistical analysis provided for Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.

18. Secondary:

Laboratory Values: Hematology Assessed at Baseline and 6 Months. [ Baseline and Month 6 ]

Measure Type	Secondary
Measure Title	Laboratory Values: Hematology Assessed at Baseline and 6 Months.
Measure Description	Comparing Lab values and differences from Baseline to month 6
Time Frame	Baseline and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Laboratory Values: Hematology Assessed at Baseline and 6 Months. [units: thousands/microliter] Mean ± Standard Deviation
WBC - Baseline	6898.49 ± 1991.34	6336.93 ± 1815.00
WBC - Month 6	6463.61 ± 1421.58	6387.03 ± 1828.81
Neutrophils - Baseline	53.46 ± 9.17	53.52 ± 8.63
Neutrophils - Month 6	52.47 ± 8.46	52.90 ± 8.51
Lymphocytes - Baseline	35.96 ± 8.03	35.87 ± 8.28
Lymphocytes - Month 6	36.96 ± 7.61	36.03 ± 8.19
Monocytes - Baseline	7.03 ± 1.64	7.03 ± 1.80
Monocytes - Month 6	7.08 ± 1.39	7.14 ± 1.75
Eosinophils - Baseline	2.81 ± 2.34	2.69 ± 1.71
Eosinophils - Month 6	2.75 ± 2.08	2.99 ± 2.21
Basophils - Baseline	0.48 ± 0.28	0.52 ± 0.28
Basophils - Month 6	0.50 ± 0.21	0.51 ± 0.26
Platelets - Baseline	249.63 ± 52.79	250.19 ± 53.67
Platelets - Month 6	243.69 ± 46.03	240.26 ± 50.90
Hemoglobin (%)- Baseline	15.44 ± 1.17	15.54 ± 0.88
Hemoglobin (%) - Month 6	15.41 ± 1.10	15.46 ± 0.86
MCV (fL)- Baseline	92.12 ± 3.31	91.89 ± 4.06
MCV (fL) - Month 6	91.57 ± 3.51	91.44 ± 3.88

No statistical analysis provided for Laboratory Values: Hematology Assessed at Baseline and 6 Months.

19. Secondary:

Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. [ Baseline and Month 6 ]

Measure Type	Secondary
Measure Title	Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.
Measure Description	sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)
Time Frame	Baseline and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. [units: IU/L] Mean ± Standard Deviation
AST(SGOT) - Baseline	23.10 ± 6.77	22.80 ± 6.14
AST(SGOT) - Month 6	25.88 ± 10.55	25.11 ± 9.51
ALT(SGPT) - Baseline	29.79 ± 15.11	26.91 ± 12.36
ALT(SGPT) - Month 6	34.00 ± 25.79	30.47 ± 18.81
Alkaline Phosphatase - Baseline	87.34 ± 40.14	85.79 ± 46.15
Alkaline Phosphatase - Month 6	85.51 ± 33.09	84.24 ± 42.44
Bilirubin (mg/dL) - Baseline	0.78 ± 0.32	0.71 ± 0.28
Bilirubin (mg/dL) - Month 6	0.80 ± 0.32	0.79 ± 0.31
Albumin (g/dL) - Baseline	4.66 ± 0.22	4.60 ± 0.25
Albumin (g/dL) - Month 6	4.64 ± 0.21	4.60 ± 0.24

No statistical analysis provided for Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.

20. Secondary:

Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. [ Baseline and Month 6 ]

Measure Type	Secondary
Measure Title	Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
Measure Description	Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)
Time Frame	Baseline and Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. [units: mg/dL] Mean ± Standard Deviation
Glucose - Baseline	104.48 ± 25.32	101.56 ± 16.17
Glucose - Month 6	104.49 ± 24.45	106.31 ± 20.82
Creatinine - Baseline	1.03 ± 0.14	1.03 ± 0.14
Creatinine - Month 6	1.05 ± 0.11	1.06 ± 0.14
Ferritine (ug/L) - Baseline	100.21 ± 55.11	131.91 ± 77.74
Ferritine (ug/L) - Month 6	109.61 ± 64.29	132.36 ± 87.91
Zinc (Hmol/L) - Baseline	111.19 ± 35.35	112.66 ± 45.62
Zinc (Hmol/L) - Month 6	118.07 ± 40.75	113.87 ± 39.80

No statistical analysis provided for Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.

21. Secondary:

Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation [ Screening ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation
Measure Description	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?
Time Frame	Screening
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation [units: Participants]
Sex Drive - No Problem	60	58
Sex Drive - Very Small Problem	5	5
Sex Drive - Small Problem	4	9
Sex Drive - Medium Problem	4	3
Sex Drive - Big Problem	0	0
Erection - No Problem	62	60
Erection - Very Small Problem	7	6
Erection - Small Problem	4	7
Erection - Medium Problem	0	2
Erection - Big Problem	0	0
Ejaculation - No Problem	64	63
Ejaculation - Very Small Problem	6	4
Ejaculation - Small Problem	3	7
Ejaculation - Medium Problem	0	1
Ejaculation - Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation

22. Secondary:

Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation [ Baseline ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation
Measure Description	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?
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation [units: Participants]
Sex Drive - No Problem	63	60
Sex Drive - Very small problem	4	5
Sex Drive - Small problem	6	8
Sex Drive - Medium problem	0	1
Sex Drive - Big problem	0	0
Erection - No Problem	64	60
Erection - Very small problem	5	6
Erection - Small problem	4	7
Erection - Medium problem	0	1
Erection - Big problem	0	0
Ejaculation - No Problem	63	62
Ejaculation - Very small problem	7	5
Ejaculation - Small problem	3	7
Ejaculation - Medium problem	0	0
Ejaculation - Big problem	0	0

No statistical analysis provided for Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation

23. Secondary:

Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation [ Month 3 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation
Measure Description	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?
Time Frame	Month 3
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation [units: Participants]
Sex Drive - No Problem	49	59
Sex Drive - Very small Problem	12	8
Sex Drive - Small Problem	5	5
Sex Drive - Medium Problem	5	0
Sex Drive - Big Problem	0	1
Erection - No Problem	52	56
Erection - Very Small Problem	11	10
Erection - Small Problem	2	3
Erection - Medium Problem	6	3
Erection - Big Problem	0	1
Ejaculation - No Problem	55	59
Ejaculation - Very Small Problem	9	8
Ejaculation - Small Problem	3	3
Ejaculation - Medium Problem	4	2
Ejaculation - Big Problem	0	1

No statistical analysis provided for Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation

24. Secondary:

Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation [ Month 6 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation
Measure Description	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?
Time Frame	Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation [units: Participants]
Sex Drive - No Problem	56	59
Sex Drive - Very Small Problem	7	6
Sex Drive - Small Problem	7	8
Sex Drive - Medium Problem	2	2
Sex Drive - Big Problem	0	0
Erection - No Problem	57	58
Erection - Very Small Problem	6	9
Erection - Small Problem	6	7
Erection - Medium Problem	3	1
Erection - Big Problem	0	0
Ejaculation - No Problem	58	59
Ejaculation - Very Small Problem	8	8
Ejaculation - Small Problem	4	6
Ejaculation - Medium Problem	2	2
Ejaculation - Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation

25. Secondary:

Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation [ Month 10 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation
Measure Description	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?
Time Frame	Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation [units: Participants]
Sex Drive - No Problem	62	62
Sex Drive - Very Small Problem	7	6
Sex Drive - Small Problem	2	4
Sex Drive - Medium Problem	1	3
Sex Drive - Big Problem	0	0
Erection - No Problem	59	60
Erection - Very Small Problem	9	11
Erection - Small Problem	4	2
Erection - Medium Problem	0	2
Erection - Big Problem	0	0
Ejaculation - No Problem	60	62
Ejaculation - Very Small Problem	7	10
Ejaculation - Small Problem	4	1
Ejaculation - Medium Problem	0	2
Ejaculation - Big Problem	1	0

No statistical analysis provided for Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation

26. Secondary:

Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive [ Baseline to Month 6 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive
Measure Description	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.
Time Frame	Baseline to Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive [units: Participants]
No Problem shift to No Problem	53	52
No Problem shift to Very Small Problem	6	4
No Problem shift to Small Problem	2	4
No Problem shift to Medium Problem	1	0
No Problem shift to Big Problem	0	0
Very Small Problem shift to No Problem	0	4
Very Small Problem shift to Very Small Problem	0	0
Very Small Problem shift to Small Problem	3	1
Very Small Problem shift to Medium Problem	1	0
Very Small Problem shift to Big Problem	0	0
Small Problem shift to No Problem	3	1
Small Problem shift to Very Small Problem	1	2
Small Problem shift to Small Problem	2	3
Small Problem shift to Medium Problem	0	2
Small Problem shift to Big Problem	0	0
Medium Problem shift to No Problem	0	1
Medium Problem shift to Very Small Problem	0	0
Medium Problem shift to Small Problem	0	0
Medium Problem shift to Medium Problem	0	0
Medium Problem shift to Big Problem	0	0
Big Problem shift to No Problem	0	0
Big Problem shift to Very Small Problem	0	0
Big Problem shift to Small Problem	0	0
Big Problem shift to Medium Problem	0	0
Big Problem shift to Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive

27. Secondary:

Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection [ Baseline to Month 6 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection
Measure Description	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.
Time Frame	Baseline to Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection [units: Participants]
No Problem shift to No Problem	53	52
No Problem shift to Very Small Problem	6	5
No Problem shift to Small Problem	3	3
No Problem shift to Medium Problem	1	0
No Problem shift to Big Problem	0	0
Very Small Problem shift to No Problem	2	3
Very Small Problem shift to Very Small Problem	0	3
Very Small Problem shift to Small Problem	2	0
Very Small Problem shift to Medium Problem	1	0
Very Small Problem shift to Big Problem	0	0
Small Problem shift to No Problem	2	1
Small Problem shift to Very Small Problem	0	1
Small Problem shift to Small Problem	1	4
Small Problem shift to Medium Problem	1	1
Small Problem shift to Big Problem	0	0
Medium Problem shift to No Problem	0	1
Medium Problem shift to Very Small Problem	0	0
Medium Problem shift to Small Problem	0	0
Medium Problem shift to Medium Problem	0	0
Medium Problem shift to Big Problem	0	0
Big Problem shift to No Problem	0	0
Big Problem shift to Very Small Problem	0	0
Big Problem shift to Small Problem	0	0
Big Problem shift to Medium Problem	0	0
Big Problem shift to Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection

28. Secondary:

Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation [ Baseline to Month 6 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation
Measure Description	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.
Time Frame	Baseline to Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation [units: Participants]
No Problem shift to No Problem	54	54
No Problem shift to Very Small Problem	5	5
No Problem shift to Small Problem	2	3
No Problem shift to Medium Problem	1	0
No Problem shift to Big Problem	0	0
Very Small Problem shift to No Problem	3	3
Very Small Problem shift to Very Small Problem	3	1
Very Small Problem shift to Small Problem	1	0
Very Small Problem shift to Medium Problem	0	1
Very Small Problem shift to Big Problem	0	0
Small Problem shift to No Problem	1	1
Small Problem shift to Very Small Problem	0	2
Small Problem shift to Small Problem	1	3
Small Problem shift to Medium Problem	1	1
Small Problem shift to Big Problem	0	0
Medium Problem shift to No Problem	0	0
Medium Problem shift to Very Small Problem	0	0
Medium Problem shift to Small Problem	0	0
Medium Problem shift to Medium Problem	0	0
Medium Problem shift to Big Problem	0	0
Big Problem shift to No Problem	0	0
Big Problem shift to Very Small Problem	0	0
Big Problem shift to Small Problem	0	0
Big Problem shift to Medium Problem	0	0
Big Problem shift to Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation

29. Secondary:

Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive [ Baseline to Month 10 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive
Measure Description	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.
Time Frame	Baseline to Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive [units: Participants]
No Problem shift to No Problem	57	55
No Problem shift to Very Small Problem	5	3
No Problem shift to Small Problem	0	0
No Problem shift to Medium Problem	0	2
No Problem shift to Big Problem	0	0
Very Small Problem shift to No Problem	2	4
Very Small Problem shift to Very Small Problem	1	0
Very Small Problem shift to Small Problem	1	1
Very Small Problem shift to Medium Problem	0	0
Very Small Problem shift to Big Problem	0	0
Small Problem shift to No Problem	3	1
Small Problem shift to Very Small Problem	1	3
Small Problem shift to Small Problem	1	3
Small Problem shift to Medium Problem	1	1
Small Problem shift to Big Problem	0	0
Medium Problem shift to No Problem	0	1
Medium Problem shift to Very Small Problem	0	0
Medium Problem shift to Small Problem	0	0
Medium Problem shift to Medium Problem	0	0
Medium Problem shift to Big Problem	0	0
Big Problem shift to No Problem	0	0
Big Problem shift to Very Small Problem	0	0
Big Problem shift to Small Problem	0	0
Big Problem shift to Medium Problem	0	0
Big Problem shift to Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive

30. Secondary:

Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection [ Baseline to Month 10 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection
Measure Description	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.
Time Frame	Baseline to Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection [units: Participants]
No Problem shift to No Problem	54	54
No Problem shift to Very Small Problem	6	5
No Problem shift to Small Problem	3	0
No Problem shift to Medium Problem	0	1
No Problem shift to Big Problem	0	0
Very Small Problem shift to No Problem	2	2
Very Small Problem shift to Very Small Problem	3	4
Very Small Problem shift to Small Problem	0	0
Very Small Problem shift to Medium Problem	0	0
Very Small Problem shift to Big Problem	0	0
Small Problem shift to No Problem	3	2
Small Problem shift to Very Small Problem	0	2
Small Problem shift to Small Problem	1	2
Small Problem shift to Medium Problem	0	1
Small Problem shift to Big Problem	0	0
Medium Problem shift to No Problem	0	1
Medium Problem shift to Very Small Problem	0	0
Medium Problem shift to Small Problem	0	0
Medium Problem shift to Medium Problem	0	0
Medium Problem shift to Big Problem	0	0
Big Problem shift to No Problem	0	0
Big Problem shift to Very Small Problem	0	0
Big Problem shift to Small Problem	0	0
Big Problem shift to Medium Problem	0	0
Big Problem shift to Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection

31. Secondary:

Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation [ Baseline to Month 10 ]

Measure Type	Secondary
Measure Title	Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation
Measure Description	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.
Time Frame	Baseline to Month 10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Dutasteride	Placebo
Number of Participants Analyzed [units: participants]	73	75
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation [units: Participants]
No Problem shift to No Problem	56	56
No Problem shift to Very Small problem	2	6
No Problem shift to Small Problem	3	0
No Problem shift to Medium Problem	0	0
No Problem shift to Big Problem	1	0
Very Small Problem shift to No Problem	2	3
Very Small Problem shift to Very Small Problem	5	1
Very Small Problem shift to Small Problem	0	0
Very Small Problem shift to Medium Problem	0	1
Very Small Problem shift to Big Problem	0	0
Small Problem shift to No Problem	2	2
Small Problem shift to Very Small Problem	0	3
Small Problem shift to Small Problem	1	1
Small Problem shift to Medium Problem	0	1
Small Problem shift to Big Problem	0	0
Medium Problem shift to No Problem	0	0
Medium Problem shift to Very Small Problem	0	0
Medium Problem shift to Small Problem	0	0
Medium Problem shift to Medium Problem	0	0
Medium Problem shift to Big Problem	0	0
Big Problem shift to No Proble	0	0
Big Problem shift to Very Small Problem	0	0
Big Problem shift to Small Problem	0	0
Big Problem shift to Medium Problem	0	0
Big Problem shift to Big Problem	0	0

No statistical analysis provided for Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106377
Study First Received:	February 27, 2007
Results First Received:	January 20, 2009
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00441116 History of Changes
Health Authority:	Korea: Food and Drug Administration