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Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product

Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product - Evaluation of the efficacy of Lactobacillus lubricant gel as a feminine care product

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043944
Enrollment
70
Registered
2021-04-16
Start date
2021-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Five pre-menopausal women without using any feminine products Fifteen pre-menopausal women using feminine soap and cream for 4 weeks Fifteen pre-menopausal women using feminine soap, cream and Lactoba

Sponsors

Aging Care Division Advanced Medical Care Co. Ltd.
Lead Sponsor
Hamamatsucho Hamasite Clinic Shinkokai Medical Corporation
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Changes in vaginal flora types, compositions, diversity index and clusters before and after the intervention at 4 weeks

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactShoji Isono

Advanced Medical Care Co. Ltd. Aging Care Division

s-isono@amcare.co.jp03-6890-0036

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026