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NCT03734523 · ClinicalTrials.gov registry record
Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
A clinical trial, sponsored by Vaginal Biome Science.
- Completed
- Registry status
- 38
- Enrollment target
NCT03734523 is a clinical trial that has completed, run by Vaginal Biome Science. The registered enrollment target is 38 participants.
The verdict
NCT03734523 has completed, sponsored by Vaginal Biome Science.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study Summary
Background Bacterial Vaginosis is the most common vaginal infection in women in their reproductive years and a difficult one to treat. In the United States, the National Health and Nutrition Examination Survey (NHANES), estimated the prevalence of BV was 29 percent in the general population of women aged 14 to 49 years and 50 percent in African-American women. It is characterized by a shift in vaginal flora from an acidic environment due to acid producing lactobacilli to a mixture of anaerobic and facultative microorganisms. BV causes symptoms of vaginal odor, itching, discharge and irritation and can greatly impact a woman's health, quality of life, sexual relations, self-image and well-being. BV has also been associated with an increased risk of preterm labor, STD acquisition and vaginal cuff cellulitis after hysterectomy6. After treatment with antibiotics, recurrences are common. About 15-30% will have recurrence in 3 months7. Normal vaginal flora is lactobacilli dominant. Lactobacilli maintain vaginal pH in the acidic range and keep the growth of BV associated bacteria at low levels. Lactobacilli also produce proteins with bactericidal activity which help to maintain their dominance. Anything that alters the vaginal flora and changes the pH to a more basic environment may increase the risk of BV. Currently, there are many sexual lubricants and vaginal moisturizers available on the market. It has recently been shown that many of these are hyperosmolar and it is thought that hyperosmolar lubricants can be damaging to the epithelium and may alter the pH of the vagina. It is postulated that lubricants and moisturizers may predispose to BV by altering the pH of the vagina. The Flourish Vaginal Care System, by Good Clean Love, includes the following three products: Restore, a 510K-cleared moisturizing personal lubricant that has been on the market for 3 years. It is available without a prescription. It is formulated to bio-match the vaginal secretions of women wi
Interventions
- COMBINATION_PRODUCT Flourish Vaginal Care System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2022-02-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03734523
The ClinicalTrials.gov registry entry for NCT03734523 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaginal Biome Science, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flourish Vaginal Care System is the first listed.
NCT03734523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03734523 about?
NCT03734523 is a clinical study titled "Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis". Background Bacterial Vaginosis is the most common vaginal infection in women in their reproductive years and a difficult one to treat. In the United States, the National Health and Nutrition Examination Survey (NHANES), estimated the prevalence of BV was 29 percent in the general population of wome...
What is the current status of trial NCT03734523?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2021-07-01. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT03734523?
The interventions under investigation include: Flourish Vaginal Care System (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03734523?
This trial is sponsored by Vaginal Biome Science, which has 9 total clinical trials registered on ClinicalTrials.gov.
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