Bacterial VaginosisVENUSNCT06472765
Vaginal Ecosystem and Network in the United States Study
An observational study of Bacterial Vaginosis and Candidiasis, run by Vaginal Biome Science at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Candidiasis, Urinary Tract Infections
- What is being tested?
- Vaginal Swab Collection
- How many people
- 3,250 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 16 May 2024to 15 May 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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)
Who may be able to join
- Healthy cis-gender women between ages 18 and 89
Who cannot join
- Pregnant or trying to conceive (i.e. IVF, IUI)
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
United States20 sites
Empowered Midwifery and Wellness LLC
Alexandria, Minnesota, 56308
Rachel Rubin MD PLLC
Bethesda, Maryland, 20814
Center for Pelvic Medicine
Bryn Mawr, Pennsylvania, 19010
Center of the Health
Corvallis, Oregon, 97330
Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine
Easton, Maryland, 21601
Women's Pelvic Health Center
Fullerton, California, 92835
Xena Health
Henderson, Nevada, 89074
Healthy Mothers, Healthy Babies Coalition of Hawaii
Honolulu, Hawaii, 96817
Empire OBGYN
Kenmore, New York, 14217
Claris Health
Los Angeles, California, 90064
University of California Los Angeles Department of Radiation Oncology
Los Angeles, California, 90095
UH Hospitals
Mayfield Heights, Ohio, 44124
Gary H Goldman, MD
New York, New York, 10128
Northwest Obstetrics and Gynecology
Oklahoma City, Oklahoma, 73112
Pelvic Pain Rehab
Pasadena, California, 91106
Amber Wellness Group
Portland, Oregon, 97213
North Houston Gynecologic Oncology Surgeons, PLLC
Shenandoah, Texas, 77384
Haven Center for Sexual Medicine & Vulvovaginal Disorders
Tulsa, Oklahoma, 74137
Hello Climax
Virginia Beach, Virginia, 23455
Camel City Women's Wellness
Winston-Salem, North Carolina, 27101
Canada1 site
Integrative Naturopathic Medical Centre
Vancouver, British Columbia, V6H 3X8
About this study
Official title: Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States
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.
Read the detailed description
This study protocol is developed to analyze the vaginal microbiome of women using a 56-panel PCR test and NGS test. The aim is to collect vaginal swab samples from a wide range of participants, including both healthy individuals and those with diagnosed gynecological conditions, to identify different microbiome profiles.
A key aspect of this study is the creation of a registry that will compile the data obtained from the PCR/NGS test results and participant information. This registry will serve as a valuable resource for ongoing research and will support the development of personalized approaches in women's health care. By systematically collecting and analyzing data, the registry will facilitate a better understanding of the vaginal microbiome's role in health and disease, aiding in the advancement of diagnostic and therapeutic strategies.
Additionally, the registry will provide a foundation for future studies, allowing for the exploration of long-term trends and relationships within the vaginal microbiome. This could lead to new insights into how the microbiome influences gynecological health and the development of targeted treatments. The combination of validating a precise diagnostic tool and establishing a comprehensive registry is aimed at enhancing patient care and supporting the broader research community in women's health.
- Conditions
- Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Genitourinary Syndrome of Menopause, Lichen Sclerosus, Lichen Planus
- Being tested
- Vaginal Swab Collection
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Urinary Tract Infections, Lichen Sclerosus et Atrophicus, Lichen Planus, Vulvodynia, Endometriosis, Ureaplasma Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Swab CollectionDiagnostic test
Vaginal Swab Collection
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Healthy | Premenopausal Healthy Receives: Diagnostic Test: Vaginal Swab Collection | |
| Perimenopausal Healthy | Perimenopausal Healthy Receives: Diagnostic Test: Vaginal Swab Collection | |
| Postmenopausal Healthy | Postmenopausal Healthy Receives: Diagnostic Test: Vaginal Swab Collection | |
| Bacterial Vaginosis | Bacterial Vaginosis Receives: Diagnostic Test: Vaginal Swab Collection | |
| Candidiasis | Yeast Infections Receives: Diagnostic Test: Vaginal Swab Collection | |
| Urinary Tract Infection | Premenopausal and Postmenopausal Women Receives: Diagnostic Test: Vaginal Swab Collection | |
| Genitourinary Syndrome of Menopause | Vaginal Atrophy Receives: Diagnostic Test: Vaginal Swab Collection | |
| Lichen Sclerosus/Planus | Lichen Sclerosus/Planus Receives: Diagnostic Test: Vaginal Swab Collection | |
| Vulvodynia | Vulvodynia Receives: Diagnostic Test: Vaginal Swab Collection | |
| Endometriosis | Endometriosis Receives: Diagnostic Test: Vaginal Swab Collection | |
| Ureaplasma | Ureaplasma Receives: Diagnostic Test: Vaginal Swab Collection | |
| Desquamative Inflammatory Vaginitis (DIV) | Desquamative Inflammatory Vaginitis (DIV) Receives: Diagnostic Test: Vaginal Swab Collection | |
| 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 Receives: Diagnostic Test: Vaginal Swab Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Registry
Data collection for future research
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start16 May 2024
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vaginal Biome Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Capone, PhD, Principal investigator, Vaginal Biome Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472765
- Sponsor's protocol ID
- CRVA2024
- Acronym
- VENUS
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States
- ClinicalTrials.gov ID
- NCT06472765
- Acronym / sponsor ID
- VENUS / CRVA2024
- Conditions
- Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Genitourinary Syndrome of Menopause, Lichen Sclerosus, Lichen Planus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,250 participants (estimated)
- Lead sponsor
- Vaginal Biome ScienceUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study protocol is developed to analyze the vaginal microbiome of women using a 56-panel PCR test and NGS test. The aim is to collect vaginal swab samples from a wide range of participants, including both healthy individuals and those with diagnosed gynecological conditions, to identify different microbiome profiles.
A key aspect of this study is the creation of a registry that will compile the data obtained from the PCR/NGS test results and participant information. This registry will serve as a valuable resource for ongoing research and will support the development of personalized approaches in women's health care. By systematically collecting and analyzing data, the registry will facilitate a better understanding of the vaginal microbiome's role in health and disease, aiding in the advancement of diagnostic and therapeutic strategies.
Additionally, the registry will provide a foundation for future studies, allowing for the exploration of long-term trends and relationships within the vaginal microbiome. This could lead to new insights into how the microbiome influences gynecological health and the development of targeted treatments. The combination of validating a precise diagnostic tool and establishing a comprehensive registry is aimed at enhancing patient care and supporting the broader research community in women's health.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Healthy | – | Diagnostic Test: Vaginal Swab CollectionPremenopausal Healthy |
| Perimenopausal Healthy | – | Diagnostic Test: Vaginal Swab CollectionPerimenopausal Healthy |
| Postmenopausal Healthy | – | Diagnostic Test: Vaginal Swab CollectionPostmenopausal Healthy |
| Bacterial Vaginosis | – | Diagnostic Test: Vaginal Swab CollectionBacterial Vaginosis |
| Candidiasis | – | Diagnostic Test: Vaginal Swab CollectionYeast Infections |
| Urinary Tract Infection | – | Diagnostic Test: Vaginal Swab CollectionPremenopausal and Postmenopausal Women |
| Genitourinary Syndrome of Menopause | – | Diagnostic Test: Vaginal Swab CollectionVaginal Atrophy |
| Lichen Sclerosus/Planus | – | Diagnostic Test: Vaginal Swab CollectionLichen Sclerosus/Planus |
| Vulvodynia | – | Diagnostic Test: Vaginal Swab CollectionVulvodynia |
| Endometriosis | – | Diagnostic Test: Vaginal Swab CollectionEndometriosis |
| Ureaplasma | – | Diagnostic Test: Vaginal Swab CollectionUreaplasma |
| Desquamative Inflammatory Vaginitis (DIV) | – | Diagnostic Test: Vaginal Swab CollectionDesquamative Inflammatory Vaginitis (DIV) |
| Cancer | – | Diagnostic Test: Vaginal Swab CollectionGroup 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (1 listed)
- Healthy cis-gender women between ages 18 and 89
Key exclusion criteria (1 listed)
- Pregnant or trying to conceive (i.e. IVF, IUI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Swab CollectionVaginal Swab Collection | Diagnostic test | Bacterial Vaginosis, Cancer, Candidiasis, Desquamative Inflammatory Vaginitis (DIV), Endometriosis, Genitourinary Syndrome of Menopause, Lichen Sclerosus/Planus, Perimenopausal Healthy, Postmenopausal Healthy, Premenopausal Healthy, Ureaplasma, Urinary Tract Infection, Vulvodynia |
Primary outcome
Microbiome Analysis
Time frame: Day 1
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.
1 secondary outcome
Registry
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Capone, PhD principal investigator
Vaginal Biome Science
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Vaginosis and Candidiasis, run by Vaginal Biome Science at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Analysis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.