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The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic AlopeciaThe 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. Study Type: Interventional Official Title: 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)
Further study details as provided by GlaxoSmithKline:
Primary Outcomes: Hair growth assessed by macrophotographic technique (hair
count) in the vertex at 6 months.
Secondary Outcomes: Subject assessment of change in hair growth and loss. Panel and investigator photographic assessment of change in hair growth Hormone measurements of LH at screening and DHT, testosterone, TSH, and T4. Assessment of sexual function Expected Total Enrollment: 150 Study start: December 2006 Eligibility
Ages Eligible for Study: 18 Years - 49 Years, Genders Eligible for
Study: Male
Criteria
Inclusion criteria:
Exclusion criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00441116
Korea, Republic of GSK Clinical Trials Call Center, Seoul, 110-744, Korea, Republic of; Recruiting
GSK Clinical Trials Call Center 1-877-379-3718
oskwon@snu.ac.kr
GSK Clinical Trials Call Center, Seoul, 140-702, Korea, Republic of; Not yet recruiting
GSK Clinical Trials Call Center 1-877-379-3718
drro@netsgo.com
GSK Clinical Trials Call Center, Seoul, 134-090, Korea, Republic of; Recruiting
GSK Clinical Trials Call Center 1-877-379-3718
sim@khnmc.or.kr
GSK Clinical Trials Call Center, Wonju, 220-701, Korea, Republic of; Recruiting
GSK Clinical Trials Call Center 1-877-379-3718
leews@wonju.yonsei.ac.kr
Study chairs or principal investigators
GSK Clinical Trials, M.D., Ph.D., Study Director, GlaxoSmithKline
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