Vaginal Ecosystem and Network in the United States Study
VENUS
Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States
1 other identifier
observational
3,250
2 countries
21
Brief Summary
The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions. Specifically, the research aims to investigate how imbalances in microbial communities, such as the overgrowth of pathogenic bacteria or the depletion of beneficial ones, are linked to conditions like Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Vaginal Atrophy, and others. By employing PCR testing and the outcomes of next-generation sequencing (NGS) of the microbiome, the study seeks to identify distinct microbial profiles and patterns that are characteristic of each condition. This nuanced understanding is expected to lead to more accurate and early diagnosis, facilitating personalized and effective treatment strategies that go beyond the conventional, often indiscriminate use of antibiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2024
CompletedFirst Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2028
July 1, 2025
June 1, 2025
3 years
June 18, 2024
June 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Microbiome Analysis
To analyze the vaginal microbiome in patients with diverse vaginal health conditions using next-generation sequencing (NGS) and a 56-panel PCR test to understand microbial diversity and implications for disease management.
Day 1
Secondary Outcomes (1)
Registry
Day 1
Study Arms (13)
Premenopausal Healthy
Premenopausal Healthy
Perimenopausal Healthy
Perimenopausal Healthy
Postmenopausal Healthy
Postmenopausal Healthy
Bacterial Vaginosis
Bacterial Vaginosis
Candidiasis
Yeast Infections
Urinary Tract Infection
Premenopausal and Postmenopausal Women
Genitourinary Syndrome of Menopause
Vaginal Atrophy
Lichen Sclerosus/Planus
Lichen Sclerosus/Planus
Vulvodynia
Vulvodynia
Endometriosis
Endometriosis
Ureaplasma
Ureaplasma
Desquamative Inflammatory Vaginitis (DIV)
Desquamative Inflammatory Vaginitis (DIV)
Cancer
Group 1: Breast cancer patients diagnosed at stages 1-3, post-menopausal (due to surgical, chemical reasons, or age-related natural processes), and currently receiving anti-estrogen treatment for a minimum of 90 days. Group 2: Breast cancer patients diagnosed at stages 1-3, pre-menopausal, and undergoing anti-estrogen endocrine therapy for at least 90 days. Group 3: Participants diagnosed with any type of cancer at stages 1-3, not receiving anti-estrogen therapy, but have been using vaginal estrogen, prasterone, or DHEA for 90 days or more. Should not be on systemic hormone replacement therapy (estrogen with or without progesterone). Group 4: Diagnosed with any type of cancer at stages 1-3, and should not be receiving any anti-estrogen therapy or using vaginal estrogen, prasterone, or DHEA. These individuals must not be on systemic hormone replacement therapy. Group 5: Participants diagnosed at stage 4
Interventions
Vaginal Swab Collection
Eligibility Criteria
This study's substantial sample size of 3,250 participants is statistically justified to ensure a diverse and representative sample of the population, providing increased statistical power for detecting variations in the vaginal microbiome. This approach not only allows for a comprehensive understanding of microbiome variability but also ensures the ethical utility of the research, making the findings significantly beneficial for a broad demographic. The following are the subgroups of conditions/individuals that will be sampled, each 250 swabs: 1. Premenopausal Healthy 2. Perimenopausal Healthy 3. Postmenopausal Healthy 4. Bacterial Vaginosis 5. Candidiasis (Yeast Infections) 6. Urinary Tract Infection (premenopausal and postmenopausal) 7. Genitourinary Syndrome of Menopause 8. Lichen Sclerosus/Planus 9. Vulvodynia 10. Endometriosis 11. Ureaplasma 12. Desquamative Inflammatory Vaginitis (DIV) 13. Cancer (various types)
You may qualify if:
- Healthy cis-gender women between ages 18 and 89
You may not qualify if:
- Pregnant or trying to conceive (i.e. IVF, IUI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Women's Pelvic Health Center
Fullerton, California, 92835, United States
Claris Health
Los Angeles, California, 90064, United States
University of California Los Angeles Department of Radiation Oncology
Los Angeles, California, 90095, United States
Pelvic Pain Rehab
Pasadena, California, 91106, United States
Healthy Mothers, Healthy Babies Coalition of Hawaii
Honolulu, Hawaii, 96817, United States
Rachel Rubin MD PLLC
Bethesda, Maryland, 20814, United States
Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine
Easton, Maryland, 21601, United States
Empowered Midwifery and Wellness LLC
Alexandria, Minnesota, 56308, United States
Xena Health
Henderson, Nevada, 89074, United States
Empire OBGYN
Kenmore, New York, 14217, United States
Gary H Goldman, MD
New York, New York, 10128, United States
Camel City Women's Wellness
Winston-Salem, North Carolina, 27101, United States
UH Hospitals
Mayfield Heights, Ohio, 44124, United States
Northwest Obstetrics and Gynecology
Oklahoma City, Oklahoma, 73112, United States
Haven Center for Sexual Medicine & Vulvovaginal Disorders
Tulsa, Oklahoma, 74137, United States
Center of the Health
Corvallis, Oregon, 97330, United States
Amber Wellness Group
Portland, Oregon, 97213, United States
Center for Pelvic Medicine
Bryn Mawr, Pennsylvania, 19010, United States
North Houston Gynecologic Oncology Surgeons, PLLC
Shenandoah, Texas, 77384, United States
Hello Climax
Virginia Beach, Virginia, 23455, United States
Integrative Naturopathic Medical Centre
Vancouver, British Columbia, V6H 3X8, Canada
Biospecimen
Vaginal swab for Next Generation Sequencing and Polymerase Chain Reaction tests.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Capone, PhD
Vaginal Biome Science
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2024
First Posted
June 25, 2024
Study Start
May 16, 2024
Primary Completion (Estimated)
May 15, 2027
Study Completion (Estimated)
May 15, 2028
Last Updated
July 1, 2025
Record last verified: 2025-06