What this trial studies
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.
Conditions in scope
- Bacterial Vaginosis
- Candidiasis
- Urinary Tract Infections
- Genitourinary Syndrome of Menopause
- Lichen Sclerosus
- Lichen Planus
- Vulvodynia
- Endometriosis
Interventions
- Vaginal Swab Collection (Diagnostic Test) — Vaginal Swab Collection
Who can join
Women only · Ages 18 Years to 89 Years · Accepts healthy volunteers.
Inclusion criteria
- Healthy cis-gender women between ages 18 and 89
Exclusion criteria
- Pregnant or trying to conceive (i.e. IVF, IUI)
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Fullerton | California | Women's Pelvic Health Center | Unknown |
| Los Angeles | California | Claris Health | Unknown |
| Los Angeles | California | University of California Los Angeles Department of Radiation Oncology | Unknown |
| Pasadena | California | Pelvic Pain Rehab | Unknown |
| Honolulu | Hawaii | Healthy Mothers, Healthy Babies Coalition of Hawaii | Unknown |
| Bethesda | Maryland | Rachel Rubin MD PLLC | Unknown |
| Easton | Maryland | Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine | Unknown |
| Alexandria | Minnesota | Empowered Midwifery and Wellness LLC | Unknown |
| Henderson | Nevada | Xena Health | Unknown |
| Kenmore | New York | Empire OBGYN | Unknown |
Showing the first 10 of 21 sites. See all sites on ClinicalTrials.gov.
Status & timeline
- Overall status: Enrolling by invitation
- Study type: Observational
- Phase: N/A
- Start date: 2024-05-16
- Primary completion: 2027-05-15
- Last update posted: 2025-07-01
- First posted: 2024-06-25
Sponsor & contact
Lead sponsor: Vaginal Biome Science (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Microbiome Analysis (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.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06472765 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.