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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

Participant Flow: Overall Study

	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

Baseline Characteristics

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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.

Baseline Measures

	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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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8. Secondary:

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

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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 ]

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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 ]

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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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 ]

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

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

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26. Secondary:

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

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27. Secondary:

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

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28. Secondary:

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

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29. Secondary:

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

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30. Secondary:

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

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31. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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.

Other Adverse Events

	Dutasteride	Placebo
Total, other (not including serious) adverse events
# participants affected	12	7
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis ^†^A # participants affected / at risk	12/73 (16.44%)	7/75 (9.33%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA

More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GSK
phone: 866-435-7343

No publications provided

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