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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019323
Receipt No. R000022342
Scientific Title Efficacy and Safety of the Tadarafil Monotherapy or Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Date of disclosure of the study information 2015/11/01
Last modified on 2016/10/15

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Basic information
Public title Efficacy and Safety of the Tadarafil Monotherapy or Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Acronym TMCTD study
Scientific Title Efficacy and Safety of the Tadarafil Monotherapy or Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Scientific Title:Acronym TMCTD study
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyse the efficacy and safety of the coadministration of Tadarafil and Dutasteride for Benign Prostatic Hyperplasis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Total international prostate symptom score on 12 weeks after administration
Key secondary outcomes Total IPSS on 24 weeks after administration
IPSS sub-score, OABSS, IIEF5, AMS Score, SF-8, Uroflowmetry, Post-voided residual volume, prostate volume, blood pressure, adverse effect on 4, 12, and 24 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tadarafil alone
5mg once a day oral administration
Interventions/Control_2 Tadarafil + Dutasteride

Tadarafil 5mg once a day oral administration
Dutasteride 0.5mg once a day oral administration
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 Male aged 50 or higher with prostate volume of 30 ml or higher and IPSS of 8 or higher
Key exclusion criteria 1) Prostate cancer
2) Neurogenic bladder
3) no administration of drugs for overactive bladder and BPH exclude a1-blocker
4) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months
5) no administration of PDE5 inhibitors
6) contraindication of Tadarafil
7) contraindication of Dutasteride
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Nishiyama
Organization Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Division name Department of Urology
Zip code
Address Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan.
TEL 025-777-3200
Email nisiyama@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Nishiyama
Organization Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
Division name Department of Urology
Zip code
Address Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan.
TEL 025-777-3200
Homepage URL
Email nisiyama@med.niigata-u.ac.jp

Sponsor
Institute Department of Urology
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Department of Urology
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
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
2015 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 Terminated
Date of protocol fixation
2015 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Because domestic supply of dutasteride had stopped and there is instability of the supply of dutasteride.

Management information
Registered date
2015 Year 10 Month 13 Day
Last modified on
2016 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022342

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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