UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032766 |
|---|---|
| Receipt number | R000037381 |
| Scientific Title | The persistence of tadalafil monotherapy and the reasons for withdrawal from treatment of treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/10/19 21:27:07 |
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Basic information
Public title
The persistence of tadalafil monotherapy and the reasons for withdrawal from treatment of treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting
Acronym
Persistence and reasons for withdrawal of tadalafil
Scientific Title
The persistence of tadalafil monotherapy and the reasons for withdrawal from treatment of treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting
Scientific Title:Acronym
Persistence and reasons for withdrawal of tadalafil
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the persistence of tadalafil monotherapy and the reasons for withdrawal from treatment of treatment-naive patients with benign prostatic hyperplasia in the real-world clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The persistence of tadalafil monotherapy and the reasons for withdrawal from treatment
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
treatment-naive patients with benign prostatic hyperplasia who have the international prostate symptom score of eight points or greater
Key exclusion criteria
urinary tract infection, acute urinary retention, prostate cancer, neurogenic bladder, the use of an alpha-1 adrenoceptor antagonist or anti-androgen, and a history of prostatic surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Yoshinori |
Organization
Hokkaido Prefectural Esashi Hospital
Division name
Division of Urology
Zip code
043-0022
Address
484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
TEL
0139-52-0036
rinoshiyokanata@me.com
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Yoshinori |
Organization
Hokkaido Prefectural Esashi Hospital
Division name
Division of Urology
Zip code
043-0022
Address
484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
TEL
0139-52-0036
Homepage URL
rinoshiyokanata@me.com
Sponsor or person
Institute
Hokkaido Prefectural Esashi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Hokkaido Prefectural Esashi Hospital
Address
484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
Tel
0139-52-0036
hofuku.esabyo2@pref.hokkaido.jg.jp
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 | 06 | 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
113
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037381
