None listed
Conditions
Sponsors
Mediogen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Females aged 40 to 65 years. 2) Individuals who meet at least one of the following: ? Postmenopausal (no menstruation for =12 months) ? Perimenopausal (no menstruation for =3 months and FSH > 30 mIU/mL) 3) Individuals with a Kupperman Index (KI) score = 25 at Visit 1. 4) Individuals with an average of =5 hot flashes per day during the past week prior to Visit 1. 5) Individuals who voluntarily agree to participate in the study and sign the Informed Consent Form (ICF) prior to the start of the human intervention study.
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal/urinary, neurologic, endocrine, psychiatric, infectious diseases, or malignant tumors. 2) Individuals with a body mass index (BMI) 30. 3) Individuals with a history of endometrial hyperplasia, uterine cancer (e.g., endometrial cancer, cervical cancer), breast cancer, or other sex hormone–related cancers (Participants who have been cured of cancers other than uterine or breast cancers or hormone-related cancers may be included if =5 years have passed since complete remission.) 4) Individuals who have undergone hysterectomy or uterine removal. 5) Individuals with abnormal uterine bleeding not diagnosed within 1 year after menopause. 6) Individuals who, within 1 year prior to Visit 1, have had: severe migraine, or have been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or have a history of percutaneous coronary intervention (PCI). 7) Individuals with severe psychiatric disorders such as depression or anxiety, or those currently taking psychotropic medications (e.g., SSRIs, gabapentin, benzodiazepines), including antidepressants or hypnotics. 8) Individuals who have used any of the following medications or products within 3 months (90 days) prior to Visit 1: ? Osteoporosis medications (e.g., bisphosphonates) ? Hormone therapies (female hormones, thyroid hormones) or phytohormonal/herbal products (e.g., black cohosh, St. John’s wort, red clover, chasteberry) ? Clonidine, anticoagulants, or antiplatelet agents (e.g., warfarin, clopidogrel) 9) Individuals who have taken menopause-related pharmaceuticals, health functional foods, or herbal medicines prescribed for menopausal symptom relief within 1 month (30 days) prior to Visit 1. 10) Individuals who have taken systemic antibiotics, systemic antimicrobials, or gastrointestinal regulators within 2 weeks prior to Visit 1. 11) Individuals who have consumed probiotics, prebiotics, or lactic acid bacteria products regularly (=4 days/week) within 2 weeks prior to Visit 1. 12) Individuals with clinically significant abnormalities in mammography (BI-RADS Category 0 or =3) or cervical cytology (ASC-US is considered not abnormal). 13) Individuals with endometrial thickness > 7 mm measured at Visit 1. 14) Individuals who consume alcohol exceeding 20 g/day (140 g/week) on average. 15) Heavy smokers, defined as smoking =20 cigarettes per day. 16) Individuals with AST (GOT) or ALT (GPT) levels =3 times the upper limit of normal. 17) Individuals with TSH = 0.1 µU/mL or = 10 µU/mL. 18) Individuals with eGFR 7.0%). 20) Individuals with uncontrolled hypertension, defined as systolic BP > 140 mmHg or diastolic BP > 90 mmHg after 10 minutes of rest. 21) Individuals who have participated in another interventional clinical trial (including human intervention studies) within 3 months prior to Visit 1 or who plan to participate in another interventional clinical trial during this study. 22) Individuals who have allergies or hypersensitivity to any components of the investigational product or placebo. 23) Individuals deemed unsuitable for participation at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Index (KI) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index (KI) score;Menopause Rating Scale (MRS) score;Number of hot flash episodes;Serum lipid profile (Total cholesterol, High density lipoprotein cholesterol(HDL-cholesterol), Low density lipoprotein cholesterol(LDL-cholesterol), Triglycerides;Fasting blood glucose;Vaginal microbiota composition | — |
Countries
Korea, Republic of
Contacts
Public ContactJiyoung Lee
Konkuk University Medical Center
Outcome results
None listed