UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039086 |
|---|---|
| Receipt number | 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 | 2022/07/11 11:26:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takehara@csc-smo.co.jp
Sponsor or person
Institute
Medical Corporation Shoureikan Sinsapporo Seiryo hospital
Institute
Department
Personal name
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
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
106
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
| 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
| 2022 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 |
