Clinical trial for efficacy of soy isoflavone in postmenopausal wome
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0001737
- Lead Sponsor
- Dr.Chung's Food
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 96
?last spontaneous menstrual bleeding>12 month ago, aged 45-60 years
?hot flushes continued for at least three month
?Kupperman index ranged 20 to 40
?Serum follicle-stimulating hormone (FSH) levels >= 40 IU /ml.
?BMI ranging between 19.0 to 30 kg/m2
?Written informed consent
? women who have hysterectomy or chemotherapy
? women who have abnormal finding such as endometrial proliferation, endometrial cancer and uterine cervical cancer related condition
? women who have breast cancer related condition
? women who received hormone replacement therapy or selective estrogen receptor modulators (SERMS) within five years of enrollment
? women who vaginal bleeding, unknown cause within six month of enrollment
? Women who have heart, kidney and thyroid disease
? Women who have depression and schizophrenia
? women who received hormone replacement therapy or selective estrogen receptor modulators (SERMS) within three month of enrollment
? Patient with systolic blood pressure =170 mmHg and diastolic pressure =100 mmHg, or hypertensive person who take diuretics (170/100 mmHg, at the screening)
? who had uncontrolled bood glucose (IFG 180 mg/dl mmHg, at the screening)
? who had soy allergy
? who participated other clinical trial within 3 months prior to this study
? who are not considrered to be appropriate to particiapt on this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hot flushes score
- Secondary Outcome Measures
Name Time Method Kupperman’s index;Menopause-specific quality of life;E2, FSH, LH, total estrogen, Total cholesterol, Triglyceride, LDL-Chol., HDL-Chol., Free Fatty Acid, NTx, CTx, Bone ALP, Osteocalcin, U-DPD;hs-CRP, sVCAM, sICAM;Adverse effects, Blood & urine, Blood pressure, Electrocardiogram