Unique ID issued by UMIN | UMIN000055042 |
---|---|
Receipt number | R000062880 |
Scientific Title | Effects of using the vaginal gel on vaginal environment: an open-label study |
Date of disclosure of the study information | 2024/07/22 |
Last modified on | 2024/07/22 14:03:46 |
Effects of using the test product on vaginal environment
Effects of using the test product on vaginal environment
Effects of using the vaginal gel on vaginal environment: an open-label study
Effects of using the vaginal gel on vaginal environment
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effects of using the vaginal gel on vaginal environment.
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of Nugent Score at 8 weeks after intervention (8w)
1. The measured values of vaginal refreshing feeling, vaginal dry feeling, vaginal itchiness, vaginal uncomfortable feeling, vulvar dry feeling, vulvar itchiness, vulvar uncomfortable feeling, amount of vaginal discharge, menstrual blood loss volume, menstrual pain, menstrual hardship, and pain during sexual intercourse at 8w
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Educational,Counseling,Training
Other |
Duration: Eight weeks
Test product: The lavage fluid
18 | years-old | <= |
Not applicable |
Female
1. Japanese
2. Women
3. Adults
4. Healthy individuals
5. Individuals who are concerned about their vaginal odor
6. Individuals whose Nugent Score is high
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are diagnosed with bacterial vaginosis, cervical cancer, or sexually transmitted disease
5. Individuals who have a medical history of toxic shock syndrome
6. Individuals who cannot collect vaginal secretions according to the established procedure with a dedicated kit
7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
8. Individuals who are taking or using medications (including herbal medicines) or supplements
9. Individuals who are allergic to medicines or foods related to the test products
10. Individuals who are pregnant, lactating, or planning to become pregnant during this study, or who are using spermicides as a method of contraception
11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
12. Individuals who are judged as ineligible to participate in this study by the physician
20
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Toyo Sugar Refining Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association Minami-machi Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2024 | Year | 07 | Month | 22 | Day |
Unpublished
Open public recruiting
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 07 | Month | 22 | Day |
2024 | Year | 12 | Month | 23 | Day |
2024 | Year | 07 | Month | 22 | Day |
2024 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062880
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |