Comparison of Pueraria mirifica Gel and Conjugated Equine Oestrogen Cream Effects on Vaginal Health in Postmenopausal Wome

Phase 3

Recruiting

• Conditions: lactobacillus grading; pueraria mirifica; postmenopausal women; vaginal dryness; Vulvovaginal symptom; vaginal cytology

• Registration Number: TCTR20150219001
• Lead Sponsor: Faculty of Medicine, Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-19
• Study Completion: 2015-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

A healthy postmenopausal women who
1. aged 40-75 years
2. last menstrual period at least one year before
3. intact uterus
4. have at least one of vulvovaginal symptom; dryness, soreness, irritation, dyspareunia or abnormal discharge
5. no contraindication for hormone therapy
6. no history of breast and any hormonal sensitive cancer

Exclusion Criteria

A women who
1. want to withdraw from the study
2. treatment adherence less than 80%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal Maturation Index 1st visit, 6-week and 12-week Vaginal cytology for assessing maturation index

Secondary Outcome Measures

Name	Time	Method
Vaginal symptom score 1st visit, 6-week, 12-week Questionaire,Vaginal assessment score 1st visit, 6-week, 12-week Pelvic examination and scored by examiner,Lactobacillus grading 1st visit, 12-week Vaginal smear for Gram stain