Neovaginal MicrobiomeNCT05372770
Flourish Vaginal Care System to Establish Neovaginal Microbiome
A study testing Flourish Vaginal Care system in people with Neovaginal Microbiome, run by Vaginal Biome Science at 1 site in United States.
Trial summary
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neovaginal Microbiome
- What is being tested?
- Flourish Vaginal Care system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Transgender women over age 18 who are preparing to undergo gender-confirmation surgery.
- Healthy cisgender women ages 18-52
Who cannot join
- Immunosuppressed
- Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh®
- Known (neo)vaginal infection that is not yeast or BV at start of protocol
- Inability to tolerate Restore gel by day 13 after surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Papillon Wellness Center
New Hope, Pennsylvania, 18938
About this study
Official title: Pilot Study to Observe Effects of Using Flourish Vaginal Care System to Establish Neovaginal Microbiome After Gender-Confirmation Surgery
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.
Read the detailed description
Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.
- Conditions
- Neovaginal Microbiome
- Being tested
- Flourish Vaginal Care system
- Keywords
- neovagina, microbiome, lactobacillus, transgender, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flourish Vaginal Care systemDevice
Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Transgender women using Flourish | Experimental | After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months. Receives: Device: Flourish Vaginal Care system |
| Group 2: Transgender women not using Flourish | No intervention | After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months. |
| Group 3: Cisgender women | Other | This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study. Receives: Device: Flourish Vaginal Care system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal microbiome
Observation of changes in the composition of the vaginal fluid microbiome over six months using commercially available next-generation sequencing kit (16s rRNA). Biomes will be categorized to "community state type" (Ravel 2011), and genus- or species-level relative abundance will be compared.
Measured: Collections at time 0, 6 weeks, and 6 months
Vaginal pH
Observation of changes in vaginal pH over six months by pH strip
Measured: Collections at time 0, 6 weeks, and 6 months
Secondary outcomes (1)
VSQ
Responses to the Vulvovaginal Symptoms Questionnaire
Measured: Collections at time 0, 6 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start24 Jan 2022
- Primary completion1 Jul 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovaginal MicrobiomeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgery
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaginal Biome Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine McGinn, DO, Principal investigator, Papillon Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372770
- Sponsor's protocol ID
- NV0122
- Status last verified
- Jun 2025
- First submitted
- 9 May 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Pilot Study to Observe Effects of Using Flourish Vaginal Care System to Establish Neovaginal Microbiome After Gender-Confirmation Surgery
- ClinicalTrials.gov ID
- NCT05372770
- Acronym / sponsor ID
- NV0122
- Conditions
- Neovaginal Microbiome
- Keywords
- neovagina, microbiome, lactobacillus, transgender, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Vaginal Biome ScienceUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 13 May 2022 (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.
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.
Detailed description
Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgery
| Arm | Type | Receives |
|---|---|---|
| Group 1: Transgender women using Flourish | Experimental | Device: Flourish Vaginal Care systemAfter gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months. |
| Group 2: Transgender women not using Flourish | No intervention | –After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months. |
| Group 3: Cisgender women | Other | Device: Flourish Vaginal Care systemThis group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Transgender women over age 18 who are preparing to undergo gender-confirmation surgery.
- Healthy cisgender women ages 18-52
Key exclusion criteria (4 listed)
- Immunosuppressed
- Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh®
- Known (neo)vaginal infection that is not yeast or BV at start of protocol
- Inability to tolerate Restore gel by day 13 after surgery.
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 |
|---|---|---|
| Flourish Vaginal Care systemFlourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components | Device | Group 1: Transgender women using Flourish, Group 3: Cisgender women |
Primary outcome
Vaginal microbiome
Time frame: Collections at time 0, 6 weeks, and 6 months
Observation of changes in the composition of the vaginal fluid microbiome over six months using commercially available next-generation sequencing kit (16s rRNA). Biomes will be categorized to "community state type" (Ravel 2011), and genus- or species-level relative abundance will be compared.
Vaginal pH
Time frame: Collections at time 0, 6 weeks, and 6 months
Observation of changes in vaginal pH over six months by pH strip
1 secondary outcome
VSQ
Time frame: Collections at time 0, 6 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Christine McGinn, DO principal investigator
Papillon Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flourish Vaginal Care system in people with Neovaginal Microbiome, run by Vaginal Biome Science at 1 site in United States.
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 2 inclusion and 4 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: finished, 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 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaginal microbiome (time frame: Collections at time 0, 6 weeks, and 6 months). The study lists 2 primary outcomes in all. 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.