UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059417 |
|---|---|
| Receipt number | R000067904 |
| Scientific Title | Baseline Survey on Male Menopausal Symptoms in Japanese Adult Males |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 13:37:54 |
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Basic information
Public title
Baseline Survey on Male Menopausal Symptoms in Japanese Adult Males
Acronym
Baseline Survey on Male Menopausal Symptoms in Japanese Adult Males
Scientific Title
Baseline Survey on Male Menopausal Symptoms in Japanese Adult Males
Scientific Title:Acronym
Baseline Survey on Male Menopausal Symptoms in Japanese Adult Males
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively collect and analyze multiple indicators related to male menopause symptoms (Late-Onset Hypogonadism syndrome) and to elucidate their interrelationships.
Basic objectives2
Others
Basic objectives -Others
To statistically analyze the relationships between various indicators and comprehensively examine the factors underlying male menopausal symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Salivary testosterone concentration
2.Salivary cortisol concentration
3.Aging Males' Symptoms (AMS) score
Key secondary outcomes
1.Basic information (age, height, weight, etc.)
2.Grip strength
3.Dietary survey (Dietary Variety Score: DVS)
4.Lifestyle habits (sleep, exercise, alcohol consumption, smoking habits, daytime posture)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | > |
Gender
Male
Key inclusion criteria
1.Male participants aged 20 years or older and 69 years or younger at the time of consent.
2.Individuals who have received a thorough explanation of the study's purpose and content and have voluntarily agreed to participate.
Key exclusion criteria
1.Individuals with periodontal disease or oral conditions, or those with a tendency for oral bleeding that may result in blood contamination during saliva collection.
2.Individuals who smoke more than 20 cigarettes per day.
3.Individuals whose daily alcohol consumption exceeds 60 grams.
4.Individuals engaged in shift work or night shifts.
5.Individuals currently participating in other clinical trials or studies, or those who participated within 4 weeks prior to obtaining consent.
6.Individuals unable to comply with the instructions of the principal investigator or deemed unsuitable by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
kimoto@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort Study
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067904
