UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005173 |
|---|---|
| Receipt number | 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 09:31:35 |
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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
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
Sponsor or person
Institute
Departments of Urology, Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006140
