Traditional Chinese medicine formulation combined with promestriene in the treatment of genitourinary syndrome of menopause (GSM) : a randomized, double-blind, controlled clinical trial

Phase 1

• Conditions: genitourinary syndrome of menopause, GSM

• Registration Number: ITMCTR2000003596
• Lead Sponsor: International Peace Maternity & Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.2 inclusion criteria
1.2.1 the postmenopausal women meeting the GSM diagnostic criteria and age over 40 years old
1.2.2 the people of no use of hormonal drugs at least 3 months
1.2.3 the people volunteered for the experiment, and signed the informed consent

Exclusion Criteria

1.3 exclusion standard
1.3.1the people without sexual partners because of unmarried, divorced, widowed and other reasons
1.3.2 the people who use GnRH - a or steroid hormone in three months
1.3.3 the people who place levonorgestrel intrauterine sustained release system into uterus
1.3.4 the people who have severe disease about heart and cerebral vessels or liver or kidney or diabetes or malignant tumor or the others.
1.3.5 the people who affect cognition on account of mental disorder or medicine or chronic drinking
1.3.6 the people who have coagulation dysfunction or thrombotic disease
1.3.7 the people who participate in other drug clinical trials

Study & Design

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

Primary Outcome Measures

Name	Time	Method
GSM Score Scale;Traditional Chinese Medicine Syndrome Score Scale;

Secondary Outcome Measures

Name	Time	Method
High-throughput sequencing technoligy for the diversity of urinary tract, reproductive tract& gut microbiota;CVFSFI Score Scale;QOL Score Scale;Cytological detection;Urodynamic test;Imaging examination of urinary system;Vaginal pH measurement and vaginal health score;Untargeted metabonomics method;Kupperman Score Scale;