UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057498 |
|---|---|
| Receipt number | R000065680 |
| Scientific Title | Study on the correlation between female hormones and bacterial flora |
| Date of disclosure of the study information | 2025/04/18 |
| Last modified on | 2025/04/03 10:16:12 |
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Basic information
Public title
Study on the correlation between female hormones and bacterial flora
Acronym
Study on the correlation between female hormones and bacterial flora
Scientific Title
Study on the correlation between female hormones and bacterial flora
Scientific Title:Acronym
Study on the correlation between female hormones and bacterial flora
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the bacterial flora using samples taken from skin in different hormonal states to understand how changes in hormonal balance associated with menopause and the menstrual cycle are related to the vulvar and vaginal microbiome.
Basic objectives2
Others
Basic objectives -Others
Observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Bacterial flora analysis
2. Fungal quantification
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. Biologically classified as female and between 20 and 60 years of age at the time of obtaining consent to participate in the study.
2. who usually use or have used tampons, have used vaginal tablets, commercial vaginal flora collection kits, or other items that must be inserted into the vagina, have had an internal examination at a gynecologist, or have given birth (in order to collect a vaginal sample).
3. Menopausal group: Those who have been menstruating for more than 1 year since their last menstrual period.
4. Hymenopausal group: Subjects whose menstrual cycle is stable between 25 and 38 days.
5. Persons who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study fully, volunteer of their own free will, and are able to give their consent through electromagnetic informed consent by the individual.
Key exclusion criteria
1. Currently suffering from any chronic disease and receiving treatment or medication from a physician, or planning to receive treatment or medication during the study period.
2. Have experienced a genital or sexually transmitted infection within the past 6 weeks.
3. Currently taking any medications (including over-the-counter medications) with female hormonal effects: (e.g., pills, hormone replacement therapy, Mother of Life, Equol, Bastmin, Himeros, etc.)
4. Persons who have been diagnosed with diabetes mellitus
5. Receiving antibiotics (any route of administration, including oral and vaginal tablets), immunosuppressive drugs, or chemotherapy medication, or will be receiving these medications during the study period. However, patients who have been taking these medications for a period of 4 weeks from the last dose at the time of entry into the study will be allowed to participate.
6. Patients who have undergone pubic hair removal procedures such as hair removal, plucking, shaving, or hair removal from the pubic area. However, procedures other than epilation are acceptable if there has been a gap of at least 4 weeks since the last procedure at the time of entry into the study.
7. Women who are pregnant, may become pregnant, or are planning to become pregnant, and women who are breastfeeding.
Excessive smokers, regular users of alcohol (more than 60 g alcohol equivalent/day), and those with an extremely irregular diet.
9. Those who are likely to undergo a major change in their living environment (e.g., move to a new residence, transfer to a new job, or travel for an extended period of time) during the study period.
10. Who are currently participating, or have participated or will participate within the next 4 weeks, in another clinical trial
11. Other subjects who are judged by the investigator to be ineligible for the study.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Harada |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Topical and Hair Care Product Development Dept.
Zip code
544-8666
Address
1-8-1 Tatsumi Nishi, Ikuno-ku, Osaka-shi, Osaka
TEL
06-6758-8213
pd3_gaiyou@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Life Science Division Clinical Trial Business Unit Operations 2G
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
080-5186-5400
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical 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
Institutional review board of Tsukiji Futaba Clinic
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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 | 04 | Month | 18 | 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 | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065680
