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Changes in Neighbouring Microbiota in Genitourinary Syndrome

NCT06633705 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-10-09

No results posted yet for this study

Summary

Genitourinary syndrome (GUS) is a disease seen in menopause, which significantly reduces the quality of life of patients. Microbiota studies in GUS are mostly related to vaginal microbiota. However, although urinary problems are also common in GUS, there are less studies on urobiome and no studies on periurethral microbiota. It is recently shown that especially in patients with dyspareunia vaginal microbiota mostly consists of Streptococcus species. As periurethral tissues are close to the skin it is reasonable to think that periurethra and vaginal opening may be colonised by aerobic bacteria which causes the symptoms like burning sensation and dyspareunia. The hypothesis of the study is that vaginal dysbiosis and related aerobic bacteria that become dominant in the periurethral microbiota may be responsible for the emergence of symptoms in menopausal patients with genitourinary syndrome. Changes in the vaginal microbiota with vaginal estrogen therapy will lead to changes in the urobiome and periurethral microbiota. Our aim is to determine the vaginal, periurethral and urinary microbiota content of menopausal women with genitourinary syndrome, to determine the effect of local estrogen therapy on them, and to examine whether there is a difference between these 3 microbiota.

Conditions

  • Genitourinary Syndrome of Menopause

Interventions

DRUG

Vaginal Cream with Applicator

Vaginal Cream that contains estriol (1mg estriol in 1 g cream)

Sponsors & Collaborators

  • Koc University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-07-10
Completion
2024-07-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633705 on ClinicalTrials.gov