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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00441116
• Collaborator: (none)
• Enrollment: 153
• Arm: 1
• Actual Duration (Months): 13.2

Study Details

Study Description

Brief Summary

The aim of this Phase III study is to compare the efficacy, safety and tolerability of dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic alopecia in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.

Condition or Disease	Intervention/Treatment	Phase
Alopecia	Drug: Dutasteride 0.5mg oral tablets	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Randomised, Double-blind, Placebo-controlled, Parallel Group 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 (Norwood-Hamilton Classification Type IIIv, IV and V)
• Actual Study Start Date: Dec 15, 2006
• Actual Primary Completion Date: Jan 21, 2008
• Actual Study Completion Date: Jan 21, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Dutasteride Dutasteride	Drug: Dutasteride 0.5mg oral tablets; Dutasteride

Outcome Measures

Primary Outcome Measures

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

   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.

Secondary Outcome Measures

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

   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.

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

   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.

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

   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.

4. 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]

   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.

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

   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.

6. 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]

   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.

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

   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.

8. 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]

   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.

9. 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]

   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.

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

    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.

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

    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.

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

    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.

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

    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.

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

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

15. 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]

    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.

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

    Sodium, Potassium (mEq/L), and Bicarbonate

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

    Comparing Lab values and differences from Baseline to month 6

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

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

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

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

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

    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?

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

    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?

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

    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?

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

    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?

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

    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?

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Rationale - The vertex area of the scalp will be evaluated during this study, therefore the inclusion criterion of Norwood Hamilton areas IIIv, IV or V ensures that subjects with vertex hair loss will be recruited in line with the primary efficacy endpoint of change in hair growth in the vertex.

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Male out-patients aged 18-49 years, inclusive

2. Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (Figure 1) (N.B. types IVa and Va are excluded)

3. Able to comprehend instructions and record required information

4. Will provide signed and dated written informed consent to participate in this investigation

Exclusion criteria:

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:

1. Evidence of hypogonadism defined as serum testosterone < 250ng/dl and/or LH

20mIU/ml Note: If the initial serum testosterone result is < 250ng/dl and the LH value is normal, the test may be repeated once. Attempts should be made, where possible, to collect all samples in the morning hours. If the repeat testosterone result is < 250ng/dl, the subject is not eligible for participation.

1. Greater than two times the upper limit of normal for ALT or AST, or a bilirubin greater than 2.0mg/dl (exception - subjects diagnosed with Gilbert's syndrome will be eligible to participate in the study)

2. Serum creatinine >1.8mg/dl

3. Global scalp hair thinning, including occipital areas

4. Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., uncontrolled seborrheic dermatitis, tinea infections, other causes of alopecia, prior hair transplants or scalp reductions, psoriatic dermatitis) and inability to discontinue use of hair weaving.

5. Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair. Subjects must maintain their natural hair colour throughout the study.

6. Hair length in non-balding areas ≤2cm (3/4 inch) around the vertex region of the head. Subjects must maintain the same hairstyle throughout the study.

7. History of malignancy within the past five years, except basal cell or squamous cell carcinoma of the skin

8. Serum PSA level > 2.0 ng/ml at screening visit.

9. Family history(Father, brothers) of prostate cancer.

10. Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for 3 months and serum TSH is normal

11. Hypersensitivity to any 5 AR inhibitor or drugs chemically related to the study medication

12. Use of finasteride or other 5 AR inhibitors within the 12 months prior to screening.

13. Previous use of dutasteride.

14. Use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.

15. Previous use of cytotoxic agents

16. Use of glucocorticoids (inhaled glucocorticoids are allowed; topical steroids are allowed provided that they are not used on the scalp) within the 3 months prior to screening

17. Use of the following during the 6 months prior to screening:

• Minoxidil (oral or topical)

• Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.

• Topical estrogen, progesterone

• Tamoxifen

• Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)

• Anabolic steroids

• Lithium and phenothiazines

1. Concurrent or regular use during the 4 weeks prior to screening of topical agents to the scalp (e.g., anti-inflammatories) 18. Participation in any investigational or marketed drug trial within 30 days preceding the screening phase of this study. Participation in any other drug trial during the course of this study including the follow-up period.

2. History or current evidence of drug or alcohol abuse within the 12 months prior screening 20. History of any illness (including psychiatric) which may impair the ability to provide informed consent or comply with study requirements 21. History of any unstable illness or condition that, in the opinion of the investigator, might confound the results or put the subject at risk.

3. Subjects who are known to be HIV positive (status which includes subjects with AIDS) 23. Subjects who will not refrain from donating blood until completing the study follow-up period.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• IPD for this study will be made available via the Clinical Study Data Request site.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00441116
• Other Study ID Numbers: 106377
• First Posted: Feb 28, 2007
• Last Update Posted: Aug 16, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: dutasteride; Androgenic alopecia; phase 3
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Dutasteride

Study Results

Participant Flow

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Period Title: Overall Study
STARTED	76	77
COMPLETED	73	75
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Dutasteride	Placebo	Total
Arm/Group Description	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.	Subjects who were given no Investigational product.	Total of all reporting groups
Overall Participants	76	77	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.78 (7.07)	38.41 (6.61)	38.097 (6.84)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	76 100%	77 100%	153 100%
Region of Enrollment (participants) [Number]
Korea, Democratic People's Republic of	76 100%	77 100%	153 (0) 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
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

Statistical Analysis Overview	Comparison Group Selection	Dutasteride, Placebo
	Comments	Month 6 - Baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0319
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	7.54
	Confidence Interval	() 95%; 0.75 to 14.33
	Parameter Dispersion	Type: Standard Deviation; Value: 20.37
	Estimation Comments	Mean difference = Drug A minus Drug B

2. Secondary Outcome

Title	Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
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)

3. Secondary Outcome

Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Much less hair (Month 3)	5 6.6%	4 5.2%
Moderately less hair (Month 3)	8 10.5%	7 9.1%
Slightly less hair (Month 3)	26 34.2%	26 33.8%
The same amount of hair (Month 3)	32 42.1%	36 46.8%
Slightly more hair (Month 3)	1 1.3%	2 2.6%
Moderately more hair (Month 3)	1 1.3%	0 0%
Much more hair (Month 3)	0 0%	0 0%
Much less hair (Month 6)	9 11.8%	7 9.1%
Moderately less hair (Month 6)	13 17.1%	8 10.4%
Slightly less hair (Month 6)	24 31.6%	22 28.6%
The same amount of hair (Month 6)	25 32.9%	35 45.5%
Slightly more hair (Month 6)	2 2.6%	3 3.9%
Moderately more hair (Month 6)	0 0%	0 0%
Much more hair (Month 6)	0 0%	0 0%

4. Secondary Outcome

Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
I strongly disagree (month 3)	0 0%	1 1.3%
I disagree (month 3)	18 23.7%	30 39%
No opinion either way (month 3)	20 26.3%	13 16.9%
I agree (month 3)	34 44.7%	30 39%
I strongly agree (month 3)	1 1.3%	1 1.3%
I strongly disagree (month 6)	0 0%	0 0%
I disagree (month 6)	18 23.7%	27 35.1%
No opinion either way (month 6)	12 15.8%	17 22.1%
I agree (month 6)	40 52.6%	29 37.7%
I strongly agree (month 6)	3 3.9%	2 2.6%

5. Secondary Outcome

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?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Much worse (Month 3)	0 0%	0 0%
Moderately worse (Month 3)	0 0%	1 1.3%
Slightly worse (Month 3)	1 1.3%	4 5.2%
Not Changed (Month 3)	36 47.4%	47 61%
Slightly Better (Month 3)	25 32.9%	20 26%
Moderately Better (Month 3)	7 9.2%	3 3.9%
Much Better (Month 3)	4 5.3%	0 0%
Much worse (Month 6)	0 0%	0 0%
Moderately worse (Month 6)	1 1.3%	0 0%
Slightly worse (Month 6)	2 2.6%	10 13%
Not changed (Month 6)	23 30.3%	33 42.9%
Slightly Better (Month 6)	26 34.2%	29 37.7%
Moderately Better (Month 6)	11 14.5%	3 3.9%
Much Better (Month 6)	10 13.2%	0 0%

6. Secondary Outcome

Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
I strongly disagree (Month 3)	0 0%	0 0%
I disagree (Month 3)	4 5.3%	8 10.4%
No opinion either way (Month 3)	5 6.6%	11 14.3%
I agree(Month 3)	62 81.6%	56 72.7%
I strongly agree (Month 3)	2 2.6%	0 0%
I strongly disagree (Month 6)	0 0%	0 0%
I disagree (Month 6)	3 3.9%	8 10.4%
No opinion either way (Month 6)	3 3.9%	9 11.7%
I agree (Month 6)	60 78.9%	58 75.3%
I strongly agree(Month 6)	7 9.2%	0 0%

7. Secondary Outcome

Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Much less scalp (month 3)	10 13.2%	3 3.9%
Moderately less scalp (month 3)	17 22.4%	11 14.3%
Slightly less scalp (month 3)	25 32.9%	17 22.1%
The same amount of scalp (month 3)	14 18.4%	26 33.8%
Slightly more scalp (month 3)	3 3.9%	14 18.2%
Moderately more scalp (month 3)	1 1.3%	4 5.2%
Much more scalp (month 3)	3 3.9%	0 0%
Much less scalp (month 6)	9 11.8%	2 2.6%
Moderately less scalp (month 6)	16 21.1%	5 6.5%
Slightly less scalp (month 6)	26 34.2%	15 19.5%
The same amount of scalp (month 6)	20 26.3%	26 33.8%
Slightly more scalp (month 6)	1 1.3%	22 28.6%
Moderately more scalp (month 6)	1 1.3%	4 5.2%
Much more scalp (month 6)	0 0%	1 1.3%

8. Secondary Outcome

Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Much less scalp (Month 3)	1 1.3%	1 1.3%
Moderately less scalp (Month 3)	2 2.6%	3 3.9%
Slightly less scalp (Month 3)	3 3.9%	14 18.2%
The same amount of scalp (Month 3)	20 26.3%	24 31.2%
Slightly more scalp (Month 3)	25 32.9%	23 29.9%
Moderately more scalp (Month 3)	15 19.7%	7 9.1%
Much more scalp (Month 3)	7 9.2%	3 3.9%
Much less scalp (Month 6)	0 0%	2 2.6%
Moderately less scalp (Month 6)	0 0%	5 6.5%
Slightly less scalp (Month 6)	2 2.6%	21 27.3%
The same amount of scalp (Month 6)	22 28.9%	28 36.4%
Slightly more scalp (Month 6)	17 22.4%	17 22.1%
Moderately more scalp (Month 6)	28 36.8%	1 1.3%
Much more scalp (Month 6)	4 5.3%	1 1.3%

9. Secondary Outcome

Title	Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Greatly decreased (Month 3)	0 0%	0 0%
Moderately decreased (Month 3)	2 2.6%	1 1.3%
Slightly decreased (Month 3)	7 9.2%	19 24.7%
Stayed the same (Month 3)	17 22.4%	21 27.3%
Slightly increased (Month 3)	26 34.2%	21 27.3%
Moderately increased (Month 3)	15 19.7%	10 13%
Greatly increased (Month 3)	6 7.9%	3 3.9%
Greatly decreased (Month 6)	0 0%	2 2.6%
Moderately decreased (Month 6)	0 0%	4 5.2%
Slightly decreased (Month 6)	0 0%	22 28.6%
Stayed the same (Month 6)	22 28.9%	26 33.8%
Slightly increased (Month 6)	22 28.9%	18 23.4%
Moderately increased (Month 6)	23 30.3%	2 2.6%
Greatly increased (Month 6)	6 7.9%	1 1.3%

10. Secondary Outcome

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?
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Much Worse (Month 3)	0 0%	0 0%
Moderately Worse (Month 3)	2 2.6%	1 1.3%
Slightly Worse (Month 3)	2 2.6%	9 11.7%
Not Changed (Month 3)	16 21.1%	28 36.4%
Slightly Better (Month 3)	28 36.8%	24 31.2%
Moderately Better (Month 3)	14 18.4%	9 11.7%
Much Better (Month 3)	11 14.5%	4 5.2%
Much Worse (Month 6)	0 0%	1 1.3%
Moderately Worse (Month 6)	0 0%	2 2.6%
Slightly Worse (Month 6)	0 0%	20 26%
Not Changed (Month 6)	21 27.6%	25 32.5%
Slightly Better (Month 6)	24 31.6%	23 29.9%
Moderately Better (Month 6)	19 25%	2 2.6%
Much Better (Month 6)	9 11.8%	2 2.6%

11. Secondary Outcome

Title	Investigator's Photographic Assessment of Improvement Distribution From Baseline
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Greatly decreased (Month 3)	0 0%	0 0%
Moderately decreased (Month 3)	1 1.3%	1 1.3%
Slightly decreased (Month 3)	0 0%	13 16.9%
No Change (Month 3)	28 36.8%	30 39%
Slightly increased (Month 3)	35 46.1%	30 39%
Moderately increased (Month 3)	8 10.5%	1 1.3%
Greatly increased (Month 3)	1 1.3%	0 0%
Greatly decreased (Month 6)	0 0%	0 0%
Moderately decreased (Month 6)	0 0%	8 10.4%
Slightly decreased (Month 6)	4 5.3%	16 20.8%
No Change (Month 6)	24 31.6%	36 46.8%
Slightly increased (Month 6)	31 40.8%	14 18.2%
Moderately increased (Month 6)	12 15.8%	1 1.3%
Greatly increased (Month 6)	2 2.6%	0 0%

12. Secondary Outcome

Title	Investigator's Photographic Assessment of Improvements From Baseline Score
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	64	67
Month 3 Mean Score	0.78 (0.79)	0.19 (0.78)
Month 6 Mean Score	0.88 (0.86)	-0.30 (0.85)

13. Secondary Outcome

Title	Panel Assessment of Improvement Distribution From Screening
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Greatly decreased (Month 3)	0 0%	0 0%
Moderately decreased (Month 3)	1 1.3%	0 0%
Slightly decreased (Month 3)	3 3.9%	14 18.2%
No change (Month 3)	28 36.8%	29 37.7%
Slightly increased (Month 3)	33 43.4%	28 36.4%
Moderately increased (Month 3)	8 10.5%	4 5.2%
Greatly increased (Month 3)	0 0%	0 0%
Greatly decreased (Month 6)	0 0%	1 1.3%
Moderately decreased (Month 6)	0 0%	4 5.2%
Slightly decreased (Month 6)	6 7.9%	29 37.7%
No Change (Month 6)	40 52.6%	32 41.6%
Slightly increased (Month 6)	20 26.3%	8 10.4%
Moderately increased (Month 6)	5 6.6%	1 1.3%
Greatly increased (Month 6)	2 2.6%	0 0%

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
% 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)

15. Secondary Outcome

Title	The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10
Description	Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.
Time Frame	Month 3, Month 6, and Month 10

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
% 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)

16. Secondary Outcome

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.
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
TSH - Baseline - Normal	70 92.1%	75 97.4%
TSH - Baseline - Abnormal	3 3.9%	0 0%
TSH - Month 6 - Normal	70 92.1%	69 89.6%
TSH - Month 6 - Abnormal	0 0%	4 5.2%
TSH - Month 10 - Normal	71 93.4%	74 96.1%
TSH - Month 10 - Abnormal	1 1.3%	1 1.3%
T4 - Baseline - Normal	73 96.1%	75 97.4%
T4 - Baseline - Abnormal	0 0%	0 0%
T4 - Month 6 - Normal	70 92.1%	71 92.2%
T4 - Month 6 - Abnormal	0 0%	2 2.6%
T4 - Month 10 - Normal	72 94.7%	74 96.1%
T4 - Month 10 - Abnormal	0 0%	1 1.3%
PSA - Screening - Normal	73 96.1%	75 97.4%
PSA - Screening - Abnormal	0 0%	0 0%
PSA - Month 6 - Normal	70 92.1%	73 94.8%
PSA - Month 6 - Abnormal	0 0%	0 0%
PSA - Month 10 - Normal	72 94.7%	75 97.4%
PSA - Month 10 - Abnormal	0 0%	0 0%
DHT - Screening - Normal	72 94.7%	74 96.1%
DHT - Screening - Abnormal	1 1.3%	1 1.3%
DHT - Month 6 - Normal	69 90.8%	69 89.6%
DHT - Month 6 - Abnormal	1 1.3%	4 5.2%
DHT - Month 10 - Normal	70 92.1%	72 93.5%
DHT - Month 10 - Abnormal	2 2.6%	3 3.9%
Testosterone - Screening - Normal	73 96.1%	74 96.1%
Testosterone - Screening - Abnormal	0 0%	1 1.3%
Testosterone - Month 6 - Normal	67 88.2%	71 92.2%
Testosterone - Month 6 - Abnormal	3 3.9%	2 2.6%
Testosterone - Month 10 - Normal	69 90.8%	74 96.1%
Testosterone - Month 10 - Abnormal	3 3.9%	1 1.3%
LH - Baseline - Normal	67 88.2%	64 83.1%
LH - Baseline - Abnormal	6 7.9%	11 14.3%

17. Secondary Outcome

Title	Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
Description	Sodium, Potassium (mEq/L), and Bicarbonate
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
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)

18. Secondary Outcome

Title	Laboratory Values: Hematology Assessed at Baseline and 6 Months.
Description	Comparing Lab values and differences from Baseline to month 6
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
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)

19. Secondary Outcome

Title	Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
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)

20. Secondary Outcome

Title	Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
Description	Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
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)

21. Secondary Outcome

Title	Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Sex Drive - No Problem	60 78.9%	58 75.3%
Sex Drive - Very Small Problem	5 6.6%	5 6.5%
Sex Drive - Small Problem	4 5.3%	9 11.7%
Sex Drive - Medium Problem	4 5.3%	3 3.9%
Sex Drive - Big Problem	0 0%	0 0%
Erection - No Problem	62 81.6%	60 77.9%
Erection - Very Small Problem	7 9.2%	6 7.8%
Erection - Small Problem	4 5.3%	7 9.1%
Erection - Medium Problem	0 0%	2 2.6%
Erection - Big Problem	0 0%	0 0%
Ejaculation - No Problem	64 84.2%	63 81.8%
Ejaculation - Very Small Problem	6 7.9%	4 5.2%
Ejaculation - Small Problem	3 3.9%	7 9.1%
Ejaculation - Medium Problem	0 0%	1 1.3%
Ejaculation - Big Problem	0 0%	0 0%

22. Secondary Outcome

Title	Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Sex Drive - No Problem	63 82.9%	60 77.9%
Sex Drive - Very small problem	4 5.3%	5 6.5%
Sex Drive - Small problem	6 7.9%	8 10.4%
Sex Drive - Medium problem	0 0%	1 1.3%
Sex Drive - Big problem	0 0%	0 0%
Erection - No Problem	64 84.2%	60 77.9%
Erection - Very small problem	5 6.6%	6 7.8%
Erection - Small problem	4 5.3%	7 9.1%
Erection - Medium problem	0 0%	1 1.3%
Erection - Big problem	0 0%	0 0%
Ejaculation - No Problem	63 82.9%	62 80.5%
Ejaculation - Very small problem	7 9.2%	5 6.5%
Ejaculation - Small problem	3 3.9%	7 9.1%
Ejaculation - Medium problem	0 0%	0 0%
Ejaculation - Big problem	0 0%	0 0%

23. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Sex Drive - No Problem	49 64.5%	59 76.6%
Sex Drive - Very small Problem	12 15.8%	8 10.4%
Sex Drive - Small Problem	5 6.6%	5 6.5%
Sex Drive - Medium Problem	5 6.6%	0 0%
Sex Drive - Big Problem	0 0%	1 1.3%
Erection - No Problem	52 68.4%	56 72.7%
Erection - Very Small Problem	11 14.5%	10 13%
Erection - Small Problem	2 2.6%	3 3.9%
Erection - Medium Problem	6 7.9%	3 3.9%
Erection - Big Problem	0 0%	1 1.3%
Ejaculation - No Problem	55 72.4%	59 76.6%
Ejaculation - Very Small Problem	9 11.8%	8 10.4%
Ejaculation - Small Problem	3 3.9%	3 3.9%
Ejaculation - Medium Problem	4 5.3%	2 2.6%
Ejaculation - Big Problem	0 0%	1 1.3%

24. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Sex Drive - No Problem	56 73.7%	59 76.6%
Sex Drive - Very Small Problem	7 9.2%	6 7.8%
Sex Drive - Small Problem	7 9.2%	8 10.4%
Sex Drive - Medium Problem	2 2.6%	2 2.6%
Sex Drive - Big Problem	0 0%	0 0%
Erection - No Problem	57 75%	58 75.3%
Erection - Very Small Problem	6 7.9%	9 11.7%
Erection - Small Problem	6 7.9%	7 9.1%
Erection - Medium Problem	3 3.9%	1 1.3%
Erection - Big Problem	0 0%	0 0%
Ejaculation - No Problem	58 76.3%	59 76.6%
Ejaculation - Very Small Problem	8 10.5%	8 10.4%
Ejaculation - Small Problem	4 5.3%	6 7.8%
Ejaculation - Medium Problem	2 2.6%	2 2.6%
Ejaculation - Big Problem	0 0%	0 0%

25. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
Sex Drive - No Problem	62 81.6%	62 80.5%
Sex Drive - Very Small Problem	7 9.2%	6 7.8%
Sex Drive - Small Problem	2 2.6%	4 5.2%
Sex Drive - Medium Problem	1 1.3%	3 3.9%
Sex Drive - Big Problem	0 0%	0 0%
Erection - No Problem	59 77.6%	60 77.9%
Erection - Very Small Problem	9 11.8%	11 14.3%
Erection - Small Problem	4 5.3%	2 2.6%
Erection - Medium Problem	0 0%	2 2.6%
Erection - Big Problem	0 0%	0 0%
Ejaculation - No Problem	60 78.9%	62 80.5%
Ejaculation - Very Small Problem	7 9.2%	10 13%
Ejaculation - Small Problem	4 5.3%	1 1.3%
Ejaculation - Medium Problem	0 0%	2 2.6%
Ejaculation - Big Problem	1 1.3%	0 0%

26. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
No Problem shift to No Problem	53 69.7%	52 67.5%
No Problem shift to Very Small Problem	6 7.9%	4 5.2%
No Problem shift to Small Problem	2 2.6%	4 5.2%
No Problem shift to Medium Problem	1 1.3%	0 0%
No Problem shift to Big Problem	0 0%	0 0%
Very Small Problem shift to No Problem	0 0%	4 5.2%
Very Small Problem shift to Very Small Problem	0 0%	0 0%
Very Small Problem shift to Small Problem	3 3.9%	1 1.3%
Very Small Problem shift to Medium Problem	1 1.3%	0 0%
Very Small Problem shift to Big Problem	0 0%	0 0%
Small Problem shift to No Problem	3 3.9%	1 1.3%
Small Problem shift to Very Small Problem	1 1.3%	2 2.6%
Small Problem shift to Small Problem	2 2.6%	3 3.9%
Small Problem shift to Medium Problem	0 0%	2 2.6%
Small Problem shift to Big Problem	0 0%	0 0%
Medium Problem shift to No Problem	0 0%	1 1.3%
Medium Problem shift to Very Small Problem	0 0%	0 0%
Medium Problem shift to Small Problem	0 0%	0 0%
Medium Problem shift to Medium Problem	0 0%	0 0%
Medium Problem shift to Big Problem	0 0%	0 0%
Big Problem shift to No Problem	0 0%	0 0%
Big Problem shift to Very Small Problem	0 0%	0 0%
Big Problem shift to Small Problem	0 0%	0 0%
Big Problem shift to Medium Problem	0 0%	0 0%
Big Problem shift to Big Problem	0 0%	0 0%

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
No Problem shift to No Problem	53 69.7%	52 67.5%
No Problem shift to Very Small Problem	6 7.9%	5 6.5%
No Problem shift to Small Problem	3 3.9%	3 3.9%
No Problem shift to Medium Problem	1 1.3%	0 0%
No Problem shift to Big Problem	0 0%	0 0%
Very Small Problem shift to No Problem	2 2.6%	3 3.9%
Very Small Problem shift to Very Small Problem	0 0%	3 3.9%
Very Small Problem shift to Small Problem	2 2.6%	0 0%
Very Small Problem shift to Medium Problem	1 1.3%	0 0%
Very Small Problem shift to Big Problem	0 0%	0 0%
Small Problem shift to No Problem	2 2.6%	1 1.3%
Small Problem shift to Very Small Problem	0 0%	1 1.3%
Small Problem shift to Small Problem	1 1.3%	4 5.2%
Small Problem shift to Medium Problem	1 1.3%	1 1.3%
Small Problem shift to Big Problem	0 0%	0 0%
Medium Problem shift to No Problem	0 0%	1 1.3%
Medium Problem shift to Very Small Problem	0 0%	0 0%
Medium Problem shift to Small Problem	0 0%	0 0%
Medium Problem shift to Medium Problem	0 0%	0 0%
Medium Problem shift to Big Problem	0 0%	0 0%
Big Problem shift to No Problem	0 0%	0 0%
Big Problem shift to Very Small Problem	0 0%	0 0%
Big Problem shift to Small Problem	0 0%	0 0%
Big Problem shift to Medium Problem	0 0%	0 0%
Big Problem shift to Big Problem	0 0%	0 0%

28. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
No Problem shift to No Problem	54 71.1%	54 70.1%
No Problem shift to Very Small Problem	5 6.6%	5 6.5%
No Problem shift to Small Problem	2 2.6%	3 3.9%
No Problem shift to Medium Problem	1 1.3%	0 0%
No Problem shift to Big Problem	0 0%	0 0%
Very Small Problem shift to No Problem	3 3.9%	3 3.9%
Very Small Problem shift to Very Small Problem	3 3.9%	1 1.3%
Very Small Problem shift to Small Problem	1 1.3%	0 0%
Very Small Problem shift to Medium Problem	0 0%	1 1.3%
Very Small Problem shift to Big Problem	0 0%	0 0%
Small Problem shift to No Problem	1 1.3%	1 1.3%
Small Problem shift to Very Small Problem	0 0%	2 2.6%
Small Problem shift to Small Problem	1 1.3%	3 3.9%
Small Problem shift to Medium Problem	1 1.3%	1 1.3%
Small Problem shift to Big Problem	0 0%	0 0%
Medium Problem shift to No Problem	0 0%	0 0%
Medium Problem shift to Very Small Problem	0 0%	0 0%
Medium Problem shift to Small Problem	0 0%	0 0%
Medium Problem shift to Medium Problem	0 0%	0 0%
Medium Problem shift to Big Problem	0 0%	0 0%
Big Problem shift to No Problem	0 0%	0 0%
Big Problem shift to Very Small Problem	0 0%	0 0%
Big Problem shift to Small Problem	0 0%	0 0%
Big Problem shift to Medium Problem	0 0%	0 0%
Big Problem shift to Big Problem	0 0%	0 0%

29. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
No Problem shift to No Problem	57 75%	55 71.4%
No Problem shift to Very Small Problem	5 6.6%	3 3.9%
No Problem shift to Small Problem	0 0%	0 0%
No Problem shift to Medium Problem	0 0%	2 2.6%
No Problem shift to Big Problem	0 0%	0 0%
Very Small Problem shift to No Problem	2 2.6%	4 5.2%
Very Small Problem shift to Very Small Problem	1 1.3%	0 0%
Very Small Problem shift to Small Problem	1 1.3%	1 1.3%
Very Small Problem shift to Medium Problem	0 0%	0 0%
Very Small Problem shift to Big Problem	0 0%	0 0%
Small Problem shift to No Problem	3 3.9%	1 1.3%
Small Problem shift to Very Small Problem	1 1.3%	3 3.9%
Small Problem shift to Small Problem	1 1.3%	3 3.9%
Small Problem shift to Medium Problem	1 1.3%	1 1.3%
Small Problem shift to Big Problem	0 0%	0 0%
Medium Problem shift to No Problem	0 0%	1 1.3%
Medium Problem shift to Very Small Problem	0 0%	0 0%
Medium Problem shift to Small Problem	0 0%	0 0%
Medium Problem shift to Medium Problem	0 0%	0 0%
Medium Problem shift to Big Problem	0 0%	0 0%
Big Problem shift to No Problem	0 0%	0 0%
Big Problem shift to Very Small Problem	0 0%	0 0%
Big Problem shift to Small Problem	0 0%	0 0%
Big Problem shift to Medium Problem	0 0%	0 0%
Big Problem shift to Big Problem	0 0%	0 0%

30. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
No Problem shift to No Problem	54 71.1%	54 70.1%
No Problem shift to Very Small Problem	6 7.9%	5 6.5%
No Problem shift to Small Problem	3 3.9%	0 0%
No Problem shift to Medium Problem	0 0%	1 1.3%
No Problem shift to Big Problem	0 0%	0 0%
Very Small Problem shift to No Problem	2 2.6%	2 2.6%
Very Small Problem shift to Very Small Problem	3 3.9%	4 5.2%
Very Small Problem shift to Small Problem	0 0%	0 0%
Very Small Problem shift to Medium Problem	0 0%	0 0%
Very Small Problem shift to Big Problem	0 0%	0 0%
Small Problem shift to No Problem	3 3.9%	2 2.6%
Small Problem shift to Very Small Problem	0 0%	2 2.6%
Small Problem shift to Small Problem	1 1.3%	2 2.6%
Small Problem shift to Medium Problem	0 0%	1 1.3%
Small Problem shift to Big Problem	0 0%	0 0%
Medium Problem shift to No Problem	0 0%	1 1.3%
Medium Problem shift to Very Small Problem	0 0%	0 0%
Medium Problem shift to Small Problem	0 0%	0 0%
Medium Problem shift to Medium Problem	0 0%	0 0%
Medium Problem shift to Big Problem	0 0%	0 0%
Big Problem shift to No Problem	0 0%	0 0%
Big Problem shift to Very Small Problem	0 0%	0 0%
Big Problem shift to Small Problem	0 0%	0 0%
Big Problem shift to Medium Problem	0 0%	0 0%
Big Problem shift to Big Problem	0 0%	0 0%

31. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dutasteride	Placebo
Arm/Group Description	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.	Subjects who were given no Investigational product.
Measure Participants	73	75
No Problem shift to No Problem	56 73.7%	56 72.7%
No Problem shift to Very Small problem	2 2.6%	6 7.8%
No Problem shift to Small Problem	3 3.9%	0 0%
No Problem shift to Medium Problem	0 0%	0 0%
No Problem shift to Big Problem	1 1.3%	0 0%
Very Small Problem shift to No Problem	2 2.6%	3 3.9%
Very Small Problem shift to Very Small Problem	5 6.6%	1 1.3%
Very Small Problem shift to Small Problem	0 0%	0 0%
Very Small Problem shift to Medium Problem	0 0%	1 1.3%
Very Small Problem shift to Big Problem	0 0%	0 0%
Small Problem shift to No Problem	2 2.6%	2 2.6%
Small Problem shift to Very Small Problem	0 0%	3 3.9%
Small Problem shift to Small Problem	1 1.3%	1 1.3%
Small Problem shift to Medium Problem	0 0%	1 1.3%
Small Problem shift to Big Problem	0 0%	0 0%
Medium Problem shift to No Problem	0 0%	0 0%
Medium Problem shift to Very Small Problem	0 0%	0 0%
Medium Problem shift to Small Problem	0 0%	0 0%
Medium Problem shift to Medium Problem	0 0%	0 0%
Medium Problem shift to Big Problem	0 0%	0 0%
Big Problem shift to No Proble	0 0%	0 0%
Big Problem shift to Very Small Problem	0 0%	0 0%
Big Problem shift to Small Problem	0 0%	0 0%
Big Problem shift to Medium Problem	0 0%	0 0%
Big Problem shift to Big Problem	0 0%	0 0%

Adverse Events

Arm/Group Title	Dutasteride		Placebo
Arm/Group Description	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.		Subjects who were given no Investigational product.
All Cause Mortality
	Dutasteride		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dutasteride		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/ (NaN)		1/ (NaN)
Endocrine disorders
Thyroid Cancer	0/73 (0%)	0	1/75 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Dutasteride		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/73 (16.4%)		7/75 (9.3%)
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis	12/73 (16.4%)		7/75 (9.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.