UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063497 |
|---|---|
| Receipt number | R000072670 |
| Scientific Title | Femtech Specimen Collection Study: A Non-interventional Prospective Observational Study |
| Date of disclosure of the study information | 2026/11/03 |
| Last modified on | 2026/11/02 09:34:17 |
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Basic information
Public title
Femtech Specimen Collection Study
Acronym
Femtech Specimen Collection Study
Scientific Title
Femtech Specimen Collection Study: A Non-interventional Prospective Observational Study
Scientific Title:Acronym
Femtech Specimen Collection Study: A Non-interventional Prospective Observational Study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in serum, saliva, vaginal discharge, and menstrual blood biomarkers associated with the menstrual cycle and age group (menopausal stage).
Basic objectives2
Others
Basic objectives -Others
Evaluation of physiological variations and differences in biomarkers in biological samples associated with the menstrual cycle and menopausal stages.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical laboratory tests
Subjective assessment questionnaires
Key secondary outcomes
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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Subjects of women having period aged 20 to 59
(2) Subjects who menstruate (excluding those in their 50s) and self-report the presence of vaginal discharge before and after menstruation.
Key exclusion criteria
(1) Subjects with a history of psychiatric, hepatic, renal, gastrointestinal, cardiovascular, respiratory, or peripheral vascular diseases, or any other serious disease
(2) Subjects diagnosed with diabetes mellitus, including those taking SGLT2 inhibitors
(3) Subjects with a history of gastrointestinal surgery
(4) Subjects with abnormal liver or renal function test results
(5) Subjects currently receiving treatment for any disease
(6) Subjects who have used antibiotics or antifungal agents within the past 4 weeks (or vaginal preparations within the past 2 weeks)
(7) Subjects who are currently using, or have used within the past 3 months, oral contraceptives, hormone replacement therapy (HRT), emergency contraception, or hormonal medications
(8) Subjects undergoing infertility treatment, including the use of ovulation-inducing agents
(9) Subjects who have undergone hysterectomy or bilateral oophorectomy
(10) Subjects with acute infection or fever (including those within 2 weeks after recovery), or who have received vaccination within the past 2 weeks
(11) Subjects with active autoimmune or inflammatory diseases
(12) Subjects currently undergoing treatment for malignant tumors or who completed such treatment less than 2 years ago
(13) Subjects diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
(14) Subjects who are pregnant, breastfeeding, or within 6 months after weaning
(15) Subjects who engage in sexual intercourse or vaginal cleansing, or use vaginal products or lubricants within 24 hours before specimen collection
(16) and beyond are described in Other related information.
Target sample size
55
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 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6809-5220
k.miura.cl@gmail.com
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 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6809-5220
mterashima@oneness-sup.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
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
| 2026 | Year | 11 | Month | 03 | 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
| 2026 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"Key exclusion criteria"
(16) Subjects receiving systemic corticosteroids or immunosuppressive agents
(17) Subjects with vaginitis, bacterial vaginosis, candidiasis, or cervicitis (current or under treatment)
(18) Subjects with recurrent unexplained abnormal uterine bleeding
(19) Subjects with allergies to foods or medications
(20) Subjects who themselves or whose relatives are currently employed by, or have previously been employed by, Unicharm Corporation or Cranebio Inc.
(21) Subjects who engage in intense sports activities or are currently dieting
(22) Subjects with extremely irregular dietary habits
(23) Subjects s who cannot discontinue the use of health foods (including Foods for Specified Health Uses and Foods with Functional Claims) or designated quasi-drugs during the study period
(24) Subjects receiving continuous treatment with medications, including OTC drugs and prescription drugs
(25) Subjects whose average daily alcohol intake exceeds 40 g of pure alcohol
(26) Subjects who smoke an average of 21 or more cigarettes per day
(27) Subjects currently participating in another clinical trial, or planning to participate in another clinical trial during the study period
(28) Subjects judged by the principal investigator or sub-investigator to be unsuitable for participation in the study
Management information
Registered date
| 2026 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072670
