UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025353 |
|---|---|
| Receipt number | 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 20:12:11 |
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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
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
waku@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine, Department of Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029167
