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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034701
Receipt No. R000039563
Official scientific title of the study Add-on treatment of dutasteridey to tadalafil for patients with benign prostatic enlargement
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/30

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Basic information
Official scientific title of the study Add-on treatment of dutasteridey to tadalafil for patients with benign prostatic enlargement
Title of the study (Brief title) Add-on treatment of dutasteridey to tadalafil for patients with benign prostatic enlargement
Region
Japan

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

Objectives
Narrative objectives1 To examine the add-on effect of dutasteride to tadalafil for patients with BPH
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of IPSS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Add-on treatment of dutasteride
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
50 years-old <=
Age-upper limit
100 years-old >
Gender Male
Key inclusion criteria Patinets with 30ml over of prostate volume and IPSS>8 or QOL>3 by 3months of tadalafil treatment
Key exclusion criteria Patients who don't accept the study
Target sample size 50

Research contact person
Name of lead principal investigator Naoki Wada
Organization Asahikawa Medical University
Division name Department or Renal and Urologic Surgery
Address 2-1 Higashi Midorigaoka Asahikawa
TEL 0166-68-2533
Email nwada@asahikawa-med.ac.jp

Public contact
Name of contact person Naoki Wada
Organization Asahikawa Medical University
Division name Department or Renal and Urologic Surgery
Address 2-1 Higashi Midorigaoka Asahikawa
TEL 0166-68-2533
Homepage URL
Email nwada@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Asahikawa Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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