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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
This study has been completed.
Study NCT00441116   Information provided by GlaxoSmithKline

First Received on February 27, 2007.   Last Updated on August 11, 2011   History of Changes
Results First Received: January 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Alopecia
Androgenetic Alopecia
Intervention: Drug: Dutasteride 0.5mg oral tablets

  Participant Flow
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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.   [ Time Frame: 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.   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: 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?   [ Time Frame: Month 3 and Month 6 ]
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11.  Secondary:   Investigator's Photographic Assessment of Improvement Distribution From Baseline   [ Time Frame: Month 3 and Month 6 ]
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12.  Secondary:   Investigator's Photographic Assessment of Improvements From Baseline Score   [ Time Frame: Month 3 and Month 6 ]
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13.  Secondary:   Panel Assessment of Improvement Distribution From Screening   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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.   [ Time Frame: Baseline to Month 6 and Month 10 ]
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17.  Secondary:   Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.   [ Time Frame: Baseline and Month 6 ]
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18.  Secondary:   Laboratory Values: Hematology Assessed at Baseline and 6 Months.   [ Time Frame: Baseline and Month 6 ]
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19.  Secondary:   Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.   [ Time Frame: Baseline and Month 6 ]
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20.  Secondary:   Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.   [ Time Frame: Baseline and Month 6 ]
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21.  Secondary:   Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation   [ Time Frame: Screening ]
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22.  Secondary:   Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation   [ Time Frame: Baseline ]
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23.  Secondary:   Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation   [ Time Frame: Month 3 ]
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24.  Secondary:   Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation   [ Time Frame: Month 6 ]
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25.  Secondary:   Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation   [ Time Frame: Month 10 ]
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26.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive   [ Time Frame: Baseline to Month 6 ]
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27.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection   [ Time Frame: Baseline to Month 6 ]
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28.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation   [ Time Frame: Baseline to Month 6 ]
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29.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive   [ Time Frame: Baseline to Month 10 ]
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30.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection   [ Time Frame: Baseline to Month 10 ]
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31.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation   [ Time Frame: Baseline to Month 10 ]
  Show Outcome Measure 31


  Serious Adverse Events
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  Other Adverse Events
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  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:
unchecked 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.
unchecked 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.


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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00441116     History of Changes
Other Study ID Numbers: 106377
Study First Received: February 27, 2007
Results First Received: January 20, 2009
Last Updated: August 11, 2011
Health Authority: Korea: Food and Drug Administration





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