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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003596
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

genitourinary syndrome of menopause, GSM

Interventions

Sponsors

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

Eligibility

Sex/Gender
Female
Age
40 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
GSM Score Scale;Traditional Chinese Medicine Syndrome Score Scale;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactHong Xu
xuhong1168@126.com+86 18017316266

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026