UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043944 |
|---|---|
| Receipt number | R000050146 |
| Scientific Title | Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product |
| Date of disclosure of the study information | 2021/04/16 |
| Last modified on | 2023/04/18 11:05:17 |
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Basic information
Public title
Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product
Acronym
Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product
Scientific Title
Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product
Scientific Title:Acronym
Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Lactobacillus containing lubricant gel as a feminine care product
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in vaginal flora types, compositions, diversity index and clusters before and after the intervention at 4 weeks
Key secondary outcomes
Comparison of the following changes before and after the intervention at 4 weeks
2. Vaginal pH
3. Lifestyle habits, well being, climacteric symptoms, overactive bladder symptoms
One time evaluation before the intervention
4. Vaginal maturation index
5. Ovarian function(E2, FSH)
6. Gut micro-flora
7. Equol producer status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Five pre-menopausal women without using any feminine products
Interventions/Control_2
Fifteen pre-menopausal women using feminine soap and cream for 4 weeks
Interventions/Control_3
Fifteen pre-menopausal women using feminine soap, cream and Lactobacillus containing lubricant gel for 4 weeks
Interventions/Control_4
Five post-menopausal women without using any feminine products
Interventions/Control_5
Fifteen postmenopausal women using feminine soap and cream for 4 weeks
Interventions/Control_6
Fifteen postmenopausal women using feminine soap, cream and Lactobacillus containing lubricant gel for 4 weeks
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Thirty five healthy pre-menopausal women (20-49 years of age)
Thirty five healthy postmenopausal women (50-75 years of age)
-Who give consent on the research
-Postmenopausal women (natural absence of menstruation over at least 12 months since the last menstrual period or FSH >= 25mIU/mL, E2<20pg/mL excluding surgical menopause
Key exclusion criteria
1. Those under treatment for urinary tract infection
2. Those under treatment for urinary stone, hydronephrosis, renal tumor, etc.
3. Those who have taken antibiotics or steroids 2 weeks before the study or during the study
4. Those who have skin lesions on skin and mucosa of external genitalia or gynecological diseases such as vaginitis (except from asymptomatic atrophic vaginitis)
5. Those considered ineligible by the investigators
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Remi |
| Middle name | |
| Last name | Yoshikata |
Organization
Shinkokai Medical Corporation
Division name
Hamamatsucho Hamasite Clinic
Zip code
102-0022
Address
Shiodome Building 2F, 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
03-5472-1100
r-yoshikata@tokyomidtown-mc.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Isono |
Organization
Advanced Medical Care Co. Ltd.
Division name
Aging Care Division
Zip code
106-0032
Address
Engyo Building 7F, 7-15-14 Roppongi, Minato-ku, Tokyo
TEL
03-6890-0036
Homepage URL
s-isono@amcare.co.jp
Sponsor or person
Institute
Aging Care Division
Advanced Medical Care Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Aging Care Division
Advanced Medical Care Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsucho Hamasite Clinic
Shinkokai Medical Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Medical Corporation of Shinkokai
Address
SVAX Nishi-Shinbashi Building, 2-39-3 Nishi-Shinbashi, Minato-ku, Tokyo
Tel
03-5408-8690
chie-nishijima@shinkokai.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050146
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0270242
Number of participants that the trial has enrolled
70
Results
Vaginal pH and pathogenic flora were reduced in both treatment groups compared to control group,especially in the treatment 2 group of postmenopausal women. Genitourinary symptoms significantly improved in 60% of premenopausal women in treatment 1 group and 81.3% of postmenopausal women in treatment 2 group compared to control group. Overactive bladder symptom scores were significantly improved in postmenopausal women suspected of having overactive bladder.
Results date posted
| 2022 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 30 | Day |
Baseline Characteristics
70 healthy Japanese women, who volunteered to participate in the study conducted at the Hamasite Clinic in Tokyo Prefecture from April to July 2021. Half of them were premenopausal women, and half were postmenopausal women. Menopause was defined as no menstruation at least 12 months since the last menstrual period, follicular stimulating hormone level of 25mIU/mL and above and estradiol level less than 20 pg/ml.
Participant flow
The recruitment process started in March 2021, using pamphlets and posters targeting the female employees at the Resorttrust, Inc., their relatives and friends. The contents include the importance of feminine care, the objectives of the study, inclusion and exclusion criteria, measurements, tests and products to be used, study period, incentive for participation, and contact details. Within one month of recruitment, seventy-three women registered for participation in the study. Among them, 70 were selected based on the inclusion and exclusion criteria by the end of March, 2021.
Adverse events
No adverse events reported.
Outcome measures
Comparison of the changes in the vaginal microbiota, genitourinary symptoms, and other related biomarkers before and after completion of treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 16 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050146
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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