Efficacy and safety of NET-1601 on menopausal symptoms; A 12week, multi-center, randomized, double-blind, placebo-controlled clinical trial

Not Applicable

Recruiting

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0004716
• Lead Sponsor: aturalendo Tech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kupperman Index total score

Secondary Outcome Measures

Name	Time	Method
Kupperman Index Line item score;K-BDI-II;Safety markers