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


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 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


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

Value
https://center6.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