NCT00441116已完成3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dutasteride
Placebo Comparator
Dutasteride
干预措施: Dutasteride 0.5mg oral tablets (Drug)
结局指标
主要结局
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
时间窗: 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.
次要结局
- Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?(Month 3 and Month 6)
- Investigator's Photographic Assessment of Improvement Distribution From Baseline(Month 3 and Month 6)
- The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10(Month 3, Month 6, and Month 10)
- Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.(Baseline and Month 6)
- Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.(Baseline and Month 6)
- Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.(Baseline and Month 3)
- The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10(Month 3, Month 6 and Month 10)
- Investigator's Photographic Assessment of Improvements From Baseline Score(Month 3 and Month 6)
- Panel Assessment of Improvement Distribution From Screening(Baseline to Month 3 and Baseline to Month 6)
- 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)
- Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation(Screening)
- 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)
- Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation(Month 6)
- Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation(Baseline to Month 10)
- Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?(Month 3 and Month 6)
- 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)
- Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?(Month 3 and Month 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)
- Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?(Month 3 and Month 6)
- 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)
- Laboratory Values: Hematology Assessed at Baseline and 6 Months.(Baseline and Month 6)
- Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.(Baseline and Month 6)
- Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation(Month 3)
- Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation(Month 10)
- Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection(Baseline to Month 6)
- Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation(Baseline to Month 6)
- Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation(Baseline)
- Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive(Baseline to Month 6)
- Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive(Baseline to Month 10)
- Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection(Baseline to Month 10)
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