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New treatment option for Bacterial Vaginosis
Official title Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
ClinicalTrials.gov ID: NCT05753813
What this study is testing
What is Phexxi?
Phexxi is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for bacterial vaginosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 54, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age 18-54
- Female
- Pre-menopausal
- Can speak and read in English
- Displays capacity for informed consent
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Honolulu, Hawaii, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 54 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Honolulu, Hawaii, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.