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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025353
Receipt No. R000029167
Scientific Title Study on improvement effect of men's menopausal symptoms due to food intake
Date of disclosure of the study information 2017/01/04
Last modified on 2019/02/26

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Basic information
Public title Study on improvement effect of men's menopausal symptoms due to food intake
Acronym Effect of food on men's menopause
Scientific Title Study on improvement effect of men's menopausal symptoms due to food intake
Scientific Title:Acronym Effect of food on men's menopause
Region
Japan

Condition
Condition late onset hypogonadism syndrome(LOH)
Classification by specialty
Endocrinology and Metabolism Urology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of improvement effect of men's menopausal symptoms due to intake of 5-aminolevulinic acid (ALA) containing foods and evaluation of safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Total serum testosterone
Testosterone in saliva
Sperm examination findings
Key secondary outcomes AMS score (Aging males' symptoms score)
SF-36v2
IIEF score
Regarding safety, blood biochemical tests, urinalysis, adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 A tablet containing 10 mg of 5-aminolevulinic acid phosphate was administered 3 tablet daily for 8 weeks
Interventions/Control_2 placebo tablet intake group for 8 weeks
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
35 years-old <=
Age-upper limit
75 years-old >
Gender Male
Key inclusion criteria 1) Japanese male aged between 35 and 75 years old at the time of acquiring consent document of participation in the examination
2) men who have consciousness of indefinite complaint of menopausal male
3) AMS score of 27 points or more and less than 50 points
4) Those who have sufficient explanation about the purpose and contents of this exam, who have the capacity to consent, voluntarily volunteer for participation after understanding well, who can agree to participate in this study in writing
5) Men who can come to the designated examination date and receive examination
6) Men who the examination responsible doctor deems appropriate participation in this exam
Key exclusion criteria 1) Those who have had medical history of malignancy in the past 3 years
2) People who has a history history of heart failure, renal failure, hepatitis B, hepatitis C, current medical history
3) People whose AST (GOT), ALT (GPT) is 1.5 times or more the upper limit of the reference value
4) People whose PSA value is 4.0 ng / mL or more
5) People who have experienced severe allergic symptoms in foods and medicines
6) Health function foods (foods for specified health use, etc.), health foods, supplements with continuous ingestion habits, those who intend to intake during the examination period
7) People who judged that doctor is inappropriate as subject of this exam
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Horie
Organization Juntendo University, Graduate School of Medicine
Division name Department of Urology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan 1138421
TEL +81-3-5802-1227
Email shorie@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Wakumoto
Organization Juntendo University, Graduate School of Medicine
Division name Department of Urology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan 1138421
TEL +81-3-5802-1227
Homepage URL
Email waku@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Medicine, Department of Urology
Institute
Department

Funding Source
Organization SBI ALA promo co.ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Juntendo University Urayasu Hospital, Teikyo University School of Medicine affiliated hospital, Men's Health Clinic Tokyo
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 順天堂大学大学院医学研究科

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 04 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
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029167

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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