UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect of withdrawing dutasteride on patients with benign prostatic hyperplasia
Title of the study (Brief title)	The Effect of withdrawing dutasteride
Region	Japan

Condition
Condition	Benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of withdrawing dutasteride on patients with benign prostatic hyperplasia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	the change of prostate size and IPSS
Key secondary outcomes	the change of the parameter on uroflowmeter and PSA

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	the patients taking dutasteride orally
Key exclusion criteria	the patinets who can't fill questionnaire about benign prostatic hyperplasia
Target sample size	250

Research contact person
Name of lead principal investigator	Matsukawa Yoshihisa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of urology
Address	65 Tsurumai, showa-ku, Nagoya
TEL	+81-52-744-2985
Email	yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person	Matsukawa Yoshihisa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of urology
Address	65 Tsurumai, showa-ku, Nagoya
TEL	+81-52-744-2985
Homepage URL
Email	yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	to investigate the effect of withdrawing dutasteride on patients with benign prostatic hyperplasia

Management information
Registered date	2016 Year 01 Month 27 Day
Last modified on	2017 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023950