Estrogen and the Urogenital Microbiome in GSM

Completed · Phase 4 · Has a placebo group

Conditions studied: Menopause

In brief

This is a study of how local estrogen treatment affects the microbiome of the vagina and bladder in postmenopausal women experiencing symptoms as part of "Genitourinary Syndrome of Menopause." The goal is to understand more about the underlying microbial changes occurring in menopause and whether these are reversible with estrogen.

Key facts

Study ID

NCT03336437

Run by

Oregon Health and Science University

People needed

40

Starts

2018-02-01

Expected to finish

2019-08-23

Last updated by the study team

2019-11-22

Who can join

Age: 40 and older, up to 89. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Postmenopausal female
• Generally healthy

You may not qualify if…

• Known allergy or contraindications to the intervention
• Use of hormone therapy in the last 3 months
• Current tamoxifen use
• Currently using vaginal pessary
• History of breast cancer or BRCA mutation
• History of uterine, ovarian or cervical cancer
• History of deep vein thrombosis or pulmonary embolism
• History of stroke or myocardial infarction
• Known thrombophilic disorder (Protein S deficiency, Protein C deficiency, antithrombin deficiency)
• Known liver disease
• Use of systemic or vaginal antibiotics in the last 2 months
• Urinary tract or vaginal infection in the last 2 months

Where it is running

• Women's Health Research Unit at Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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