Study of efficacy to improve vaginal health of live lactobacilli in combination with low dose estriol tablet in menopause women with vaginal atrophy

Phase 3

Recruiting

• Conditions: atrophic vaginitisvaginal atrophypostmenopause; atrophic vaginitis; vaginal atrophy; menopause; postmenopause; Gynoflor; Premarin; Lactobacilli; Estriol; Estrogen

• Registration Number: TCTR20140305001
• Lead Sponsor: Department of Obstetrics and Gynecology Faculty of Medicine Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-05
• Study Completion: 2014-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

-Postmenopause women who visit Gynecology OPD, Ramathibodi hospital
-Have at least 1clinical symptom and 1sign of vaginal atrophy
-Vaginal pH>5

Exclusion Criteria

-existing or suspected estrogen-dependent neoplastic disease or breast cancer
-vaginal bleeding of unknown origin
-hypersensitivity to study medication
-hormonal therapy less than 3 months prior to screening
-acute infections of the genital tract
-use of any vaginal therapy
-severe systemic diseases
-all contraindications for administration of estrogen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maturation value 1month Calculate from Maturation index

Secondary Outcome Measures

Name	Time	Method
Vaginal pH 1month Universal indicater