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
- Registration Number
- NCT00441116
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 153
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dutasteride Dutasteride 0.5mg oral tablets Dutasteride
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. Baseline and Month 6 Sodium, Potassium (mEq/L), and Bicarbonate
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. Baseline and Month 6 Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)
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.
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.
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.
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.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.
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?
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.
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?
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.
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.
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.
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.
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.
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.
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.
Laboratory Values: Hematology Assessed at Baseline and 6 Months. Baseline and Month 6 Comparing Lab values and differences from Baseline to month 6
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)
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?
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?
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.
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.
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?
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.
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.
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.