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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004716

Enrollment

100

Registered

2020-02-07

Start date

2019-11-12

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Efficacy and safety of NET-1601 on menopausal symptoms

A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial - Experimantal group Daily intake and ingestion method -Test foods: Take 2 tablets twice a day for 12 weeks -- placebo group

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Kupperman Index total score	—

Secondary

Measure	Time frame
Kupperman Index Line item score;K-BDI-II;Safety markers	—

Countries

Korea, Republic of

Contacts

Public ContactJI YOUNG Lee

Konkuk University Medical Center

Outcome results