UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055649 |
|---|---|
| Receipt number | R000063597 |
| Scientific Title | Clinical trial for predicting menstrual period -Open-label study- |
| Date of disclosure of the study information | 2024/09/29 |
| Last modified on | 2025/03/04 11:11:00 |
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Basic information
Public title
Clinical trial for predicting menstrual period
Acronym
Clinical trial for predicting menstrual period
Scientific Title
Clinical trial for predicting menstrual period -Open-label study-
Scientific Title:Acronym
Clinical trial for predicting menstrual period -Open-label study-
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the match premenstrual behavior of protein levels in the discharge and menstrual start date
Basic objectives2
Others
Basic objectives -Others
Test sample retrieval test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of protein in the discharge
Results of the survey
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
The test product is used daily from 7 days before the expected start of menstruation until the onset of menstruation. Perform 2 cycles.
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Subjects of women aged 18 to 55
(2) Subjects who are menstruating and aware of discharge just before menstruation
(3) Subjects who recieved sufficient explanation about the purpose and consent, voluntarily volunteered to participate after understanding it well, and agreef to participate in the tset in wriring
Key exclusion criteria
(1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease
(2) Subjects who have undergone surgery on the digestive organs
(3) Subjects with abnormal liver function and renal function test values
(4) Subjects with diseases currently being treated
(5) Subjects who are allergic to foods and drugs
(6) Subjects with anemia symptoms
(7) Subjects with a diagnosis of endometrial disease
(8) Subjects with excessive irregular bleeding
(9) Subjects with a history of mental disease
(10) Women undergoing infertility treatment and those who have been diagnosed with polycystic ovary syndrome
(11) Use of hormonal contraceptives, use of hormone replacement therapy, fertility drugs, artificial insemination, IVF, ICSI
Those who are undergoing other medical treatments, such as adjuvant fertility therapy
(12) Subjects less than 1 year postpartum
(13) Subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects
(14) Subjects or a close family member who works for Cranebio Co., Ltd., Unicharm Co., Ltd., or their affiliates.
(15) Subjects who play intense sports and subjects who are on a diet
(16) Subjects with extremely irregular eating habits
(17) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(18) Subjects who are continuously receiving medical treatment (including OTC and prescription drugs)
(19) Subjects taking pills for menstrual regulation
(20) Subjects who drink more than 60 g of average daily pure alcohol
(21) Subjects who smoke an average of 21 or more cigarettes a day
(22) and (23) are listed in the "Other related infrmation" column.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Cranebio Co., 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 29 | 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
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"Key exclusion criteria"
(22) Subjects who are participating in or will participate in other clinical trials at the start of this study
(23) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063597
