The effects of KGC08EA on efficacy and safety to improve in Andropause symptoms : A 8-week, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0009341
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 96
1) Men over 40 years of age
2) Subjects with a total testosterone value of less than 3.5 ng/mL or male menopausal symptom survey (AMS) score of 27 or higher
3) Subjects who has signed the consent form after being briefed on this study
1) For the purpose of treating symptoms related to men's menopause, people who have taken phosphodiesterase-5 inhibitors, androgen agent, testosterone replacement therapy, statins, fibrates, niacin, steroids, fish oil, anti-obesity treatment, ezetimibe, omega-3 fatty acids, bile acid sequesters, fiber-based laxatives phytosterol margarines, and erectile dysfunction treatments
2) People who has taken diuretics, beta blockers, anticoagulants, or antiplatelet drugs
3) People with a history of hypertension, coronary artery disease, myocardial infarction, angina, heart failure, ischemic heart disease, arrhythmia, cerebral infarction, cerebral hemorrhage, stroke, diabetes, or thyroid disease
4) People with psychogenic menopausal disorder
5) People whose liver function test (AST, ALT, Total bilirubin, Alkaline Phosphatase) value is 2.5 times higher than the normal value
6) People who has a history of renal failure or has a renal function test (creatinine) that is more than 30% higher than the normal value
7) People with prostate specific antigen (PSA) = 4.0 ng/mL
8) People with Hepatitis B Test Positive
9) People with body mass index (BMI) = 35 kg/m2
10) People with a history of alcoholism or substance abuse
11) People with a history of cancer
12) People who has a hypersensitivity to test products
13) People who is at risk of serious drug interaction due to a concomitant drug
14) People who is medically and mentally prohibited from taking investigation drugs
15) People who is legally unable to participate in clinical trials
16) People who participates in another study within six months before the study
17) People who is likely to have an uncooperative attitude in this study or a person who is judged by the researcher to be unable to proceed with the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ASM survey
- Secondary Outcome Measures
Name Time Method ADAM survey, IIEF survey;Hormone biomarkers [total testosterone, free testosterone, sex hormone-bound globulin, insulin like growth factor-1], lipid biomarkers [total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides], body composition [skeletal muscle mass, body fat mass, muscle mass, abdominal fat percentage, body fat volume (visceral fat area, subcutaneous fat area, total fat area)] ;Vital signs, physical examination and measurement, clinical examination, adverse drug reactions, drug use history