comparison of Pueraria minifica gel and placebo gel effects on vaginal microenvironment among postmenopausal women with genitourinary syndrome of menopause (GSM)

Phase 2

Active, not recruiting

• Conditions: postmenopausal women with genitourinary syndrome of menopause (GSM); Pueraria mirifica; Placebo; Genitourinary Syndrome of Menopause; Vaginal Microenvironment

• Registration Number: TCTR20160517002
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-17
• Study Completion: 2016-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

postmenopausal women with genitourinary syndrome of menopause
no history of external hormone used in 3 month

Exclusion Criteria

participants who had sexually transmitted diseases, breast or female genital tract malignancy, or had taken any sex hormones within the past three months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vaginal flora index 12 weeks nugent score

Secondary Outcome Measures

Name	Time	Method
ph, gram strain and grading, modified amsell criteria, endometrium thickening 12 weeks PV, TVS, wel smear, gram stain