Estrogen and the Urogenital Microbiome in GSM

NCT03336437 | Completed Phase 4 DMC

• 1 other identifier: OHSU IRB# 17056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 goal is to understand more about the underlying microbial changes occurring in menopause and whether these are reversible with estrogen.

Conditions

Menopause

Keywords

Menopause; Vaginal dryness; Vaginal atrophy; Postmenopause; Estrogen; Urinary microbiome; Estradiol vaginal ring; Genitourinary Syndrome of Menopause; Vaginal microbiome

Outcome Measures

Primary Outcomes (1)

• Urinary Microbiome: change in the relative abundance of urinary lactobacillus between baseline and 12 weeks post intervention

  Investigators will collect catheterized urine samples from participants at time of enrollment in the study and again after 12 weeks of their assigned vaginal ring intervention. Bacteria will be extracted from the urine and the resident microbial community will be characterized by amplifying the bacterial 16S ribosomal RNA gene via PCR. The de-identified samples containing amplified 16S DNA will be sequenced using Illumina MiSeq. The genetic sequences will be processed to generate a table of bacterial identity and relative quantity. Statistical tests designed for microbiome data will be used in order to determine differences between the relative amount of lactobacillus (via the lactobacillus ratio) before and after the intervention.

  Baseline to 12 weeks post-intervention

Secondary Outcomes (1)

• Change in prevalence of GSM symptoms

  Baseline to 12 weeks post-intervention

Study Arms (2)

Estrogen Vaginal Ring

ACTIVE COMPARATOR

At the time of initial study visit, a estrogen vaginal ring (Estring) will be placed. Participants will retain this ring for 12 weeks.

Drug: Estradiol vaginal ring

Inactive Vaginal Placebo Ring

PLACEBO COMPARATOR

At the time of initial study visit, a placebo vaginal ring will be placed. Participants will retain this ring for 12 weeks.

Other: Placebo vaginal ring

Interventions

Estradiol vaginal ring DRUG

Estradiol 2mg vaginal ring

Estrogen Vaginal Ring

Placebo vaginal ring OTHER

Silicone vaginal ring without any active estradiol

Inactive Vaginal Placebo Ring

Eligibility Criteria

• Age: 40 Years - 89 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Women's Health Research Unit at Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Lillemon JN, Karstens L, Nardos R, Garg B, Boniface ER, Gregory WT. The Impact of Local Estrogen on the Urogenital Microbiome in Genitourinary Syndrome of Menopause: A Randomized-Controlled Trial. Female Pelvic Med Reconstr Surg. 2022 Jun 1;28(6):e157-e162. doi: 10.1097/SPV.0000000000001170. Epub 2022 Apr 15.

  PMID: 35420551 DERIVED

Study Officials

• Jennifer Lillemon

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: House Officer

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 8, 2017
• Study Start: February 1, 2018
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)