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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005173
Receipt No. R000006140
Scientific Title The clinical effects of dutasteride on the systemic body
Date of disclosure of the study information 2011/03/14
Last modified on 2013/09/02

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Basic information
Public title The clinical effects of dutasteride on the systemic body
Acronym The clinical effects of dutasteride on the systemic body
Scientific Title The clinical effects of dutasteride on the systemic body
Scientific Title:Acronym The clinical effects of dutasteride on the systemic body
Region
Japan

Condition
Condition The patients with late-onset hypogonadism and benign prostate hypertrophy
Classification by specialty
Endocrinology and Metabolism Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the secondary effects of increase in serum testosterone level by dutasteride administration
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To study the clinical effects of dutasteride administration on glucose, lipid and muscle metabolism
Key secondary outcomes To evaluate the effects as follwing:
1) Voiding symptoms for BPH
2) Prostate volume
3) Prostate specific antigen level
4) Bone mineral density
5) Erectile function
6) adverse effects

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 drug administration
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
90 years-old >
Gender Male
Key inclusion criteria The patients with LOH syndrome and BPH can be enrolled in this study.
1) serum testosterone<11.8 pg/ml (The criteria of LOH syndrome)
2) the patients with PSA<4.0ng/ml or the ones with PSA>=4.0ng/ml who are unlikely to have prostate cancer clinically
3) ageg range 50 from 90
4) the patients who can be obtained informed consents before entry of this study
5) performance status; 0 to 2
6) GOT and GTP more than 1.5 times the upper limits of the normal range, and Cr more than 2.0 times the upper limits of the normal range
7) the patients without any complications to treatimmdiately at the hospitalization
Key exclusion criteria 1) prior usages of another anti-androgen drug
2) prior useage of finasteride
3) the patients with prostate cancer
4) the patients who have difficulty in receiving any checks or examinations according to the study protocol
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Mizokami
Organization Kanazawa University Graduate School of Medical Science
Division name Integrative Cancer Therapy and Urology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University Graduate School of Medical Science
Division name Integrative Cancer Therapy and Urology
Zip code
Address
TEL 076-265-2393
Homepage URL
Email

Sponsor
Institute Departments of Urology, Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2011 Year 03 Month 14 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
2013 Year 04 Month 30 Day
Date trial data considered complete
2013 Year 06 Month 30 Day
Date analysis concluded
2013 Year 07 Month 20 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 02 Day
Last modified on
2013 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006140

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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