A 12-week randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HX112 on menopausal symptoms.
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0007932
- Lead Sponsor
- Helixmith
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 120
1) Postmenopause(passed one year since the last menstrual period) woman aged between 45 and 60 years.
2) FSH > 30 mIU/mL
3) Kupperman Index score = 20
4) Woman who has agreed to participate in this study and written an informed consent
1) BMI (Body Mass Index) = 30 Kg/m2
2) Woman who has used female hormones (or similar hormone products) within 3 months
3) Woman who has hasmedical history such as endometrial hyperplasia, cervical cancer, endometrial cancer, breast cancer, or estrogen dependent tumor
4) Woman who has severe migraine within the last year, thromboembolism, cerebrovascular disease, or cardiovascular disease
5) Woman who has severe mental illness, such as depression and anxiety disorder, or are currently taking psychosomatic drugs such as antidepressants
6) Woman with metrorrhagia after one year of menopause
7) Drug or alcohol abuser
8) Woman with uncontrolled thyroid disease
9) Woman with abnormal mammography/PAP smear (BI-RADS Category > 3, PAP smear > ASCUS
10) Woman who used Clonidine, anticoagulant agent(Warfarin, Aspirin, Clipidogrel within 3 months
11) Taking a medicine or health functional foods that affects menopause symptoms within 1 month
12) taking osteoporosis drugs such as bisphosphonates
13) having participated in any other clinical trials within the past 3 months
14) Woman who has abnormal laboratory tests
? AST, ALT = three times over the normal limit
? Serum Creatinine > 2.0 mg/dl
15) Woman who are judged by the investigator to be inappropriate to participate in the study due to laboratory test results and other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kupperman Index
- Secondary Outcome Measures
Name Time Method MENQOL-K; lipid profiles;Estradiol, FSH