UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on improvement effect of men's menopausal symptoms due to food intake
Title of the study (Brief title)	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	Shigeo Horie
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Urology
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	Yoshiaki Wakumoto
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Urology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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