UMIN-CTR Clinical Trial

Basic information
Public title	Investigating symptoms and clinical significance of steroid profiles for benign prostatic hypertrophy with 5alpha-reductase inhibitor
Acronym	Investigating symptoms and clinical significance of steroid profiles for benign prostatic hypertrophy with 5alpha-reductase inhibitor
Scientific Title	Investigating symptoms and clinical significance of steroid profiles for benign prostatic hypertrophy with 5alpha-reductase inhibitor
Scientific Title:Acronym	Investigating symptoms and clinical significance of steroid profiles for benign prostatic hypertrophy with 5alpha-reductase inhibitor
Region	Japan

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

Objectives
Narrative objectives1	The aim of our present study is to investigate symptoms and to evaluate the utility of steroid profiles, and we clarify the indication of the treatment with 5alpha-reductase inhibitor for benign prostatic hypertrophy more accurately.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the association between the efficacy of treatment with 5alpha-reductase inhibitors and steroid profiles.
Key secondary outcomes

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 with benign prostatic hypertrophy who received the treatment with 5alpha-reductase inhibitor at Keio University Hospital
Key exclusion criteria	The patients who have prostate cancer, or who did not agree with the purpose of this study
Target sample size	300

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Eiji Kikuchi
Organization	Keio University School of Medicine
Division name	Department of Urology
Zip code
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name
Organization	Keio University School of Medicine
Division name	Department of Urology
Zip code
Address
TEL	03-5363-3825
Homepage URL
Email

Sponsor
Institute	Department of Urology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 29 Day
Date of IRB	2010 Year 03 Month 29 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2019 Year 05 Month 17 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 05 Month 17 Day
Date analysis concluded	2019 Year 05 Month 17 Day

Other
Other related information	Case control sampling and prospective study

Management information
Registered date	2010 Year 05 Month 06 Day
Last modified on	2019 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004330