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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: February 27, 2007   Last Updated: June 23, 2009   History of Changes
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
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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
No text entered.

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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

8.  Secondary:   Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?   [ Month 3 and Month 6 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

11.  Secondary:   Investigator's Photographic Assessment of Improvement Distribution From Baseline   [ Month 3 and Month 6 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 23

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 ]
  Show Outcome Measure 25

26.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive   [ Baseline to Month 6 ]
  Show Outcome Measure 26

27.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection   [ Baseline to Month 6 ]
  Hide Outcome Measure 27

Measure Type Secondary
Measure Title Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection
Measure Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.

Reporting Groups
  Description
Dutasteride Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Placebo Subjects who were given no Investigational product.

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

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



28.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation   [ Baseline to Month 6 ]
  Show Outcome Measure 28

29.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive   [ Baseline to Month 10 ]
  Show Outcome Measure 29

30.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection   [ Baseline to Month 10 ]
  Show Outcome Measure 30

31.  Secondary:   Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation   [ 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
No text entered.  


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





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