Effects of a lactic acid gel on vaginal health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the impact of the contraceptive method Phexxi on the vaginal microbiome, specifically its ability to promote lactic acid-producing lactobacilli. It employs a pre-post study design, assessing participants' vaginal microbiome before and after a four-week course of Phexxi. The primary outcomes include an increase in beneficial lactobacilli and a reduction in symptoms of vulvovaginitis. The study is conducted at Queen's Medical Center, where eligible patients will be approached by clinicians for participation.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Queens Medical Center, 1004 Clinic POB1
  Honolulu, Hawaii, United States Recruiting

Study contacts

• Principal investigator: Olivia Manayan, MD, MPH — University of Hawaii
• Study coordinator: Olivia H Manayan, MD, MPH
• Email: omanayan@hawaii.edu
• Phone: 808-348-7859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.