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Exploring Phexxi Gel for Vaginal Microbiome Changes

This study is looking into how an intravaginal gel called Phexxi affects the natural balance of bacteria in the vagina (vaginal microbiome). Researchers want to see if using Phexxi twice a week for four weeks can increase the amount of good bacteria (lactic acid-producing lactobacilli). This could potentially help prevent repeated bacterial vaginosis (BV) and yeast infections (vulvovaginal candidiasis). You might be able to join if you are a woman between 18 and 54 years old, are pre-menopausal, and have had at least two BV or yeast infections in the past year. The study aims to see if Phexxi changes your vaginal microbiome after 30 and 60 days. The current recruitment status is unclear.

Study design
This is a single-center study that will look at participants' vaginal microbiome before and after using Phexxi. It plans to enroll 22 participants.
What's involved
You would use Phexxi intravaginal gel twice weekly for four weeks. You would also have vaginal swabs taken at the beginning, after 30 days, and after 60 days.
Compensation
Not stated in the trial record.
Follow-up
Your vaginal microbiome will be assessed 30 days and 60 days after your initial swab collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05753813

Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome

Recruiting
EARLY_PHASE1Ages 18–54InterventionalBasic science
Queen's Medical Center
~22 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Phexxi

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess participant's baseline vaginal microbiome makeup
Measured over Within one week of recruitment, unless menstruating. If this is the case, the participant will be asked to wait 10 days from the cessation of menses in order to allow restoration of baseline vaginal microbiome
+5 more outcomes measured

Conditions

Bacterial Vaginosis
Vulvovaginal Candidiasis

Explore related trials

Bacterial VaginosisVulvovaginal Candidiasis

NCT05753813

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Queens Medical Center, 1004 Clinic POB1

    Honolulu, Hawaiistudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Olivia Manayan, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Hawaii
  • Bliss Kaneshiro, MD, MPH · PRINCIPAL_INVESTIGATOR · Queen's Medical Center
  • Corrie Miller, DO · PRINCIPAL_INVESTIGATOR · University of Hawaii

Who to contact

Olivia H Manayan, MD, MPH
[email protected]
808-348-7859
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Age 18-54
Female
Pre-menopausal
Can speak and read in English
Displays capacity for informed consent
Has had 2 or more documented and/or self-reported episodes of symptomatic BV or candida infection in the last year, requiring, over-the-counter or prescription treatment

Exclusion

Pregnant or trying to become pregnant
Post-menopausal
Using NuvaRing device
A past medical history of kidney disease, recurrent UTI, and/or urinary tract abnormalities
Current UTI
Using Phexxi as a contraceptive during the collection period of the study

What this trial measures

  • To assess participant's baseline vaginal microbiome makeupWithin one week of recruitment, unless menstruating. If this is the case, the participant will be asked to wait 10 days from the cessation of menses in order to allow restoration of baseline vaginal microbiome

    NextGen analysis pre-intervention

  • To assess if the use of Phexxi causes changes in the vaginal microbiome from baseline after thirty days of use30 days after baseline vaginal swab collection

    NextGen analysis immediately post-intervention

  • To assess if the use of Phexxi causes changes in the vaginal microbiome60 days after baseline vaginal swab collection

    NextGen analysis 30 days post-completion of intervention

  • To assess participant's baseline vulvovaginitis symptomsOn day of recruitment to the study

    Survey to be completed pre-intervention

  • To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants30 days after baseline vaginal swab collection

    Survey to be completed immediately post-intervention. This survey is a validated tool to assess for symptoms of vulvovaginitis (Vulvovaginal Symptoms Questionnaire, or VSQ). It employs a binary scoring system, giving 0 points for no and 1 point for yes, with 21 questions which assess vulvovaginitis symptoms.

  • To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants60 days after baseline vaginal swab collection

    Survey to be completed 30 days post-completion of intervention. This survey is a validated tool to assess for symptoms of vulvovaginitis (Vulvovaginal Symptoms Questionnaire, or VSQ). It employs a binary scoring system, giving 0 points for no and 1 point for yes, with 21 questions which assess vulvovaginitis symptoms.