A 12-week randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HX112 on menopausal symptoms.

Helixmith0 个研究点目标入组 120 人开始时间: 待定最近更新: 2023年1月10日

适应症

试验速览

暂无简介。

•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

发起方

Helixmith