Status:
COMPLETED
Estrogen and the Urogenital Microbiome in GSM
Lead Sponsor:
Oregon Health and Science University
Conditions:
Menopause
Eligibility:
FEMALE
40-89 years
Phase:
PHASE4
Brief Summary
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 goa...
Detailed Description
Women who have undergone menopause almost ubiquitously experience pelvic complaints at some point in the postmenopausal period. This is most commonly vaginal dryness and discomfort during sexual inter...
Eligibility Criteria
Inclusion
- Postmenopausal female
- Generally healthy
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03336437
Start Date
February 1 2018
End Date
August 23 2019
Last Update
November 22 2019
Active Locations (1)
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1
Women's Health Research Unit at Oregon Health and Science University
Portland, Oregon, United States, 97239