Efficacy and safety of SGE on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003788
• Lead Sponsor: Bioland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

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

Inclusion Criteria

1) 40 to 60 year-old women who have passed one year since the last menstrual period or who have FSH 30 mIU/ml without uterus
2) Kupperman Index score of 20 of more

Exclusion Criteria

1) BMI(Body Mass Index) > 30Kg/m2
2) Hormone therapy within the past 3 months
3) Subject with severe mental illness, such as depression and anxiety disorder, or who is currently taking neuro-psychotic drugs such as antidepressants
4) When a clinically significant abnormality (BI-RADS(Breast Imaging Reporting and Data System) Category 0 or 3 or more, PAP smear(Papanicolaou smear) is normal up to ASCUS(Atypical Squamous Cell Undetermined Significance)) is confirmed from Mammography/PAP smear
5) Subject who is taking osteoporosis drugs such as Bisphosphonate

Study & Design

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

Primary Outcome Measures

Name	Time	Method
kupperman Index;Alkaline phosphatase;Osteocalcin;C-terminal telopeptide

Secondary Outcome Measures

Name	Time	Method
Estradiol, Follicle stimulating hormone, Endometrial thickness