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NCT05665569 · ClinicalTrials.gov registry record · NA
Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders
A NA study, sponsored by Vaginal Biome Science.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT05665569 is a NA study that was terminated before completion, run by Vaginal Biome Science. The registered enrollment target is 1 participants.
The verdict
NCT05665569, a NA study, was terminated before completion, sponsored by Vaginal Biome Science.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth. The main question it aims to answer is: • Can improving the vaginal microbiome allow women to improve muscle strength, improve muscle tone, and reduce tissue inflammation faster than women who do not use a vaginal hygiene system to improve their microbiome? Over a 3-month period, participants will be assessed three times for: * vaginal microbiome * vaginal pH * pelvic muscle strength * pelvic muscle tension * vulvovaginal tissue color At each of these 3 assessments, women will answer questions on a questionnaire. Half of the women will be asked to use a vaginal hygiene system at home during these 3 months. Researchers will compare use of a three-product vaginal hygiene system plus a specific vaginal lubricant to see if using these products improves the vaginal microbiome and the pelvic floor outcomes listed above.
Interventions
- DEVICE Flourish HEC, which contains BioNourish
- OTHER Routine pelvic physical therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-01-30 |
| Est. Completion | 2023-03-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05665569
The ClinicalTrials.gov registry entry for NCT05665569 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 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 2 interventions - of which Flourish HEC, which contains BioNourish is the first listed.
NCT05665569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05665569 about?
NCT05665569 is a clinical study titled "Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders". The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth. The main question it aims to answer is: • Can improving the vaginal microbiome allow women to improve muscle strength, improve muscle tone, and reduce ...
What is the current status of trial NCT05665569?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2023-01-30. Estimated completion is 2023-03-29.
What interventions are being tested in trial NCT05665569?
The interventions under investigation include: Flourish HEC, which contains BioNourish (DEVICE), Routine pelvic physical therapy (OTHER).
Who is sponsoring clinical trial NCT05665569?
This trial is sponsored by Vaginal Biome Science, which has 9 total clinical trials registered on ClinicalTrials.gov.
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