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Sponsors and Collaborators: |
Samsung Medical Center Handok Pharmaceuticals Co., Ltd. The Korean Urological Association |
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Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00679315 |
The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in female patients with voiding dysfunction.
Condition | Intervention | Phase |
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Female Voiding Dysfunction |
Drug: alfuzosin hydrochloride XL 10mg Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female: An 8 Week Prospective, Randomized Double Blind, Placebo-Controlled, Parallel Group Study (Phase Ⅱ) |
Estimated Enrollment: | 280 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
alfuzosin hydrochloride XL 10mg
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Drug: alfuzosin hydrochloride XL 10mg
One tablet to be taken daily after a meal before bedtime for 8 weeks.
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2: Placebo Comparator
Placebo
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Drug: Placebo
One tablet to be taken daily after a meal before bedtime for 8 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kyu-Sung Lee, Ph.D | 82-2-3410-3554 | ksleedr@skku.edu |
Korea, Republic of | |
Asan Medical Center, Ulsan College of Medicine | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Myung-Soo Choo mschoo@amc.seoul.kr | |
Principal Investigator: Myung-Soo Choo | |
Kangnam St. Mary's Hospital, The Catholic University of Korea | Recruiting |
Seoul, Korea, Republic of, 137-701 | |
Contact: Joon Chul Kim kjc@catholic.ac.kr | |
Principal Investigator: Joon Chul Kim | |
Anam Hospital, College of Medicine, Korea University | Recruiting |
Seoul, Korea, Republic of, 136-705 | |
Contact: Jeong Gu Lee jeongkl@kumc.or.kr | |
Principal Investigator: Jeong Gu Lee | |
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University | Recruiting |
Seoul, Korea, Republic of, 100-380 | |
Contact: Ju Tae Seo jtandro@cgh.co.kr | |
Principal Investigator: Ju Tae Seo | |
Pusan National University Hospital | Recruiting |
Pusan, Korea, Republic of, 602-739 | |
Contact: Jeong Zoo Lee toohotman@hanmail.net | |
Principal Investigator: Jeong Zoo Lee | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Seung June Oh sjo@snu.ac.kr | |
Principal Investigator: Seung June Oh | |
Holy Family Hospital, The Catholic University of Korea | Recruiting |
Kyonggi-do, Korea, Republic of, 420-717 | |
Contact: Ji Youl Lee uroljy@catholic.ac.kr | |
Principal Investigator: Ji Youl Lee | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of | |
Contact: Yong Gil yongna@cnu.ac.kr | |
Principal Investigator: Yong Gil Na. | |
Korea, Republic of, Seoul | |
Samsung Medical Center | Recruiting |
50 Ilwon-Dong, Kangnam-Gu, Seoul, Korea, Republic of, 135-710 | |
Contact: Kyu-Sung Lee 82-2-3410-3554 ksleedr@skku.edu | |
Sub-Investigator: Young-Suk Lee, MD |
Principal Investigator: | Myung-Soo Choo, Ph.D | Asan Medical Center, Ulsan College of Medicine |
Principal Investigator: | Joon Chul Kim, Ph.D | Kangnam St. Mary's Hospital, The Catholic University of Korea |
Principal Investigator: | Jeong Gu Lee, Ph.D | Anam Hospital, College of Medicine, Korea University |
Principal Investigator: | Ju Tae Seo, Ph.D | Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University |
Principal Investigator: | Jeong Zoo Lee, Ph.D | Pusan National University Hospital |
Principal Investigator: | Seung June Oh, Ph.D | Seoul National University Hospital |
Principal Investigator: | Ji Youl Lee, Ph.D | Holy Family Hospital, The Catholic University of Korea |
Principal Investigator: | Yong Gil Na., Ph.D | Chungnam National University Hospital |
Responsible Party: | Samsung Medical Center ( Kyu-Sung Lee/Professor ) |
Study ID Numbers: | ALFUS_L_02533 |
Study First Received: | May 14, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00679315 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
female voiding dysfunction alpha adrenoreceptor antagonists IPSS or American Urological Association symptom index |
Alfuzosin |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Adrenergic Antagonists Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions |