CTRI/2020/11/028988已完成未知
Randomized, Double-blinded, Placebo-controlled Study of UBPN01 to Evaluate Efficacy and Safety onHealthy Subjects with Postmenopausal Syndrome
DBIO Pharma Co Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female between 40 to 60 years (both inclusive) of age at the time of enrolment.
- •2. Female who are in the state of menopause (amenorrhea for 12 consecutive months) or transition
- •to menopause (for FSH > 30 IU/L without menstruation for more than 3 months)
- •3. Female with moderate to severe menopausal symptoms (modified Kupperman Index total score
- •>= 25 point)
- •4. A person who agrees to participate in this study and signs a written consent
排除标准
- •1.Women with a body mass index (BMI) greater than 30 kg / m2
- •2.Women undergoing HRT (Hormone Replacement Therapy) treatment to relieve menopausal symptoms within 1 month
- •3.Women taking the following food supplements to relieve menopausal symptoms within 1 month. The food can be a part of regular meal. Though, if any food is being used as a remedy or medication to relieve symptoms, it will be considered as exclusion criteria: Phytoestrogen containing food, Vitamins, Herb extract, Ginseng product, Omega 3, DHEA, Gamma linoleic acid.
- •4.Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or breast disease, sex hormone related cancer
- •5.A woman with a history of severe migraine within the past year or who has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or underwent coronary angioplasty
- •6.Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
- •7.Women with irregular uterine bleeding after 1 year of menopause
- •8.Patients with uncontrolled hypertension (160 /100mmHg or more, After 10 minutes of stabilization)
- •9.Uncontrolled diabetes mellitus patients (fasting blood sugar more than 180mg/dL or starting a new drug due to diabetes within 3 months)
- •10.Patients with thyroid disease whose TSH is less than or equal to 0.1 μU / ml or more than 10 μU / ml
- •11.drug or alcohol abuser
- •12.If ALT or AST exceeds 3 times the normal upper limit of the research institute
- •13.Creatinine exceeds twice the normal upper limit of research institute
- •14.If a clinically significant abnormality is confirmed by mammography (BI-RADS: Breast Imaging-Reporting and data system Category 0 or 3 or higher. However, in case of BI-RADS category 0, registration is possible at the discretion of the examiner)
- •15.Female with an endometrial thickness greater than 5mm by vaginal sonogram.
- •16.Have participated or planned to participate in other clinical trials within the past month
- •17.Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months
- •18.Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation
- •19.Those who investigator judges inappropriate to participate in this study. The reason for this consideration should be recorded in the source document.
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