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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034704
Receipt No. R000039549
Scientific Title Noninferior crossover study to evaluate blood testosterone improvement using new testosterone gel.
Date of disclosure of the study information 2018/10/30
Last modified on 2019/03/13

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Basic information
Public title Noninferior crossover study to evaluate blood testosterone improvement using new testosterone gel.
Acronym The study to evaluate blood testosterone improvement using new testosterone gel.
Scientific Title Noninferior crossover study to evaluate blood testosterone improvement using new testosterone gel.
Scientific Title:Acronym The study to evaluate blood testosterone improvement using new testosterone gel.
Region
Japan

Condition
Condition Late onset hypogonadism
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate improvement of blood testosterone and symptoms
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes blood testosterone level
Key secondary outcomes Aging Males' Symptoms Score

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 new testosterone gel for 4 weeks
Interventions/Control_2 AndroForte 2 for 4 weeks as a standard treatment
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
40 years-old <=
Age-upper limit
75 years-old >
Gender Male
Key inclusion criteria Japanese men with mild LOH (more than 27 of Aging males' symptoms score (AMS score)
Key exclusion criteria Prostatic cancer
Polycythemia
Sleep apnea syndrome
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Shirai
Organization Juntendo University, Urayasu Hospital
Division name Department of Urology
Zip code 2790021
Address 2-1-1, Tomioka, Urayasu City, Chiba, Japan
TEL +81473533111
Email masatos@juntendo-urayasu.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Shirai
Organization Juntendo University Urayasu Hospital
Division name Department of Urology
Zip code 2790021
Address 2-1-1, Tomioka, Urayasu City, Chiba, Japan
TEL +81473533111
Homepage URL
Email masatos@juntendo-urayasu.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization Juntendo University Urayasu Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Men's health clinic, Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Urayasu Hospital
Address 2-1-1, Tomioka, Urayasu-city, Chiba, Japan
Tel +81473533111
Email rinri-urayasu@juntendo-urayasu.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 順天堂大学浦安病院(千葉県)Juntendo University Urayasu Hospital
メンズヘルスクリニック東京(東京都)Men’s health clinic, Tokyo

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 30 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 20
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
2018 Year 04 Month 15 Day
Date of IRB
2018 Year 05 Month 22 Day
Anticipated trial start date
2018 Year 10 Month 30 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039549

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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