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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039086
Receipt No. R000044577
Scientific Title A study to evaluate menopausal symptoms in middle-aged women.
Date of disclosure of the study information 2020/01/31
Last modified on 2021/01/13

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Basic information
Public title A study to evaluate menopausal symptoms in middle-aged women.
Acronym A study to evaluate menopausal symptoms in middle-aged women.
Scientific Title A study to evaluate menopausal symptoms in middle-aged women.
Scientific Title:Acronym A study to evaluate menopausal symptoms in middle-aged women.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of a test food on the menopausal symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire for assessment of menopausal symptoms
Key secondary outcomes Blood test value

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily intakes of a test food for 6 months
Interventions/Control_2 Daily intakes of a placebo food for 6 months
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
60 years-old >
Gender Female
Key inclusion criteria 1. Japanese premenopausal women aged over 40 but less than 60.
2. Individuals who have no climacteric disorder and have several climacteric symptoms.
3. Individuals who have normal estrogen production.
4. Individuals who have a normal menstrual cycles.
5. Individuals who can write informed consent, and come to the designated venue for this study.

Key exclusion criteria 1. Individuals being patient or have a history of serious disease of liver, kidney, heart, thyroid, internal organs and diabetes.
2. Individuals who have a history of ovariectomy or hysterectomy, who are taking medications for menopausal symptoms.
3. Individuals who have internal medical chronic diseases.
4. Individuals who are constantly using medicines and functional health foods that promote menopausal symptoms.
5. Shift workers including late-night shift.
6. Individuals who are pregnant, breastfeeding, and wish to become pregnant during the test.
7. Individuals who have excessively smoking or alcohol drinking habits.
8. Individuals judged inappropriate for the trial by the principal.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Susumu
Middle name
Last name Ishikawa
Organization Medical Corporation Shoureikan Sinsapporo Seiryo hospital
Division name Internal Medicine
Zip code 004-0004
Address 4-2-1-30, Atsubetsuhigashi, Atsubetsu-ku, Sapporo, Hokkaido
TEL 011-898-2151
Email Ishikawa_seiryo@yahoo.co.jp

Public contact
Name of contact person
1st name Isao
Middle name
Last name Takehara
Organization Clinical Support Corporation Co., Ltd.
Division name PI-Food Service Division
Zip code 060-0061
Address 4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido
TEL 011-223-3130
Homepage URL
Email takehara@csc-smo.co.jp

Sponsor
Institute Medical Corporation Shoureikan Sinsapporo Seiryo hospital
Institute
Department

Funding Source
Organization Asahi Quality & Innovations, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of the Medical Corporation Hokubukai Utsukushigaoka Hospital
Address 61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel 001-882-0111
Email matsuda@ughp-cpc.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
2020 Year 01 Month 31 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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 11 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2020 Year 02 Month 28 Day
Last follow-up date
2020 Year 12 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
2020 Year 01 Month 08 Day
Last modified on
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044577

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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