UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034701 |
|---|---|
| Receipt number | R000039563 |
| Scientific Title | 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 | 2023/01/29 15:44:04 |
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Basic information
Public title
Add-on treatment of dutasteridey to tadalafil for patients with benign prostatic enlargement
Acronym
Add-on treatment of dutasteridey to tadalafil for patients with benign prostatic enlargement
Scientific Title
Add-on treatment of dutasteridey to tadalafil for patients with benign prostatic enlargement
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Naoki Wada |
Organization
Asahikawa Medical University
Division name
Department or Renal and Urologic Surgery
Zip code
Address
2-1 Higashi Midorigaoka Asahikawa
TEL
0166-68-2533
nwada@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Wada |
Organization
Asahikawa Medical University
Division name
Department or Renal and Urologic Surgery
Zip code
Address
2-1 Higashi Midorigaoka Asahikawa
TEL
0166-68-2533
Homepage URL
nwada@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
