KCT0004716招募中未知
Efficacy and safety of NET-1601 on menopausal symptoms; A 12week, multi-center, randomized, double-blind, placebo-controlled clinical trial
aturalendo Tech0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 70(Year)（—）
- 性别
- Female
入选标准
- •1) Women 40 to 70 years of age who are in the menopause ( FSH 30 mIU / ml of higher, Women without uterus )
- •2) Women with a KMI (kupperman index) score of 20 or higher
- •3) Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent form
排除标准
- •1) BMI(Body Mass Index) > 28Kg/m2
- •2) Hormone therapy within the past 3 months
- •3) Subject with a history of endometrial hyperplasia, endometrial cancer, breast disease, sex hormone related cancer
- •4)Subject with have a severe migraine within one year, have been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or have had a history of coronary angioplasty
- •5) Those who are currently taking psychological drugs such as antidepressants
- •6) Subject with unexplained uterine bleeding after 1 year of menopause
- •7) Subject with uncontrolled hypertension(160/100mmHg or higher, after 10 minutes of clinical test subjects
- •8) Subject with Uncontrolled hyperlipidemia (more than 300 mg / dL of triglycerides or more than 300 mg / dL of total cholesterol
- •9) Subject with Uncontrolled diabetes mellitus (fasting blood glucose> 180 mg / dL)
- •10) Subject with Uncontrolled thyroid disease (those deemed able to participate in this clinical trial by the investigator may participate)
- •11) History of drug abuse, or alcoholism
- •12) Subject with AST(GOT) or ALT(GPT) or ?-GTP = 3 times the upper limit of normal
- •13) Subject with serum creatinine = 2 times the upper limit of normal
- •14) If a clinically significant abnormality (BI-RADS Category 0 or 3 or greater) is identified by Mammography / PAP smear (However, in case of BI-RADS Category 0, registration can be done after checking the additional test result, and in case of PAP smear, up to ASCUS)
- •15) Subject with have used thyroid hormones, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months
- •16) Subject with have taken women's menopausal medicines or dietary supplements within 1 month
- •17) Endometrium thickness of 12 mm or more before menopause, 5 mm or more after menopause
- •18) Subject with sensitive or allergic to foods for human testing
- •19) Subject who participated in any clinical trial within 1 month or plan to participate in the other clinical study
- •20) Inappropriate subject decided by the investigator
研究者
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