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Acidifying Agent

Lactic Acid Gel for Vaginal Infections

Phase < 1

Recruiting

Led By Olivia Manayan, MD, MPH

Research Sponsored by Queen's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18-54

Must not have

Current UTI

Post-menopausal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how a contraceptive pill affects the bacteria in the vagina & if it can reduce infections.

Who is the study for?

This trial is for pre-menopausal females aged 18-54 who have had at least two episodes of BV or candida infection in the past year. Participants must speak English and be able to consent. Those with current UTIs, pregnancy, post-menopause status, NuvaRing use, kidney issues, or using Phexxi are excluded.

What is being tested?

The study tests if Phexxi (an intravaginal contraceptive gel) alters the vaginal microbiome by promoting lactic acid-producing lactobacilli growth. This could potentially help prevent recurrent bacterial vaginosis and yeast infections.

What are the potential side effects?

While not explicitly stated here, common side effects of products like Phexxi may include local irritation or discomfort, changes in discharge, urinary tract symptoms, or potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had at least 2 yeast or BV infections in the last year that needed treatment.

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I am between 18 and 54 years old.

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I have not gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have a urinary tract infection (UTI).

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I have gone through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on day of recruitment to the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on day of recruitment to the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and on day of recruitment to the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess if the use of Phexxi causes changes in the vaginal microbiome

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

To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants

+2 more

Secondary study objectives

To assess patient satisfaction/acceptability of this intervention as a therapeutic/prophylactic agent for recurrent vulvovaginitis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study groupExperimental Treatment1 Intervention

This is a single-arm study. all participants are assigned to this arm. all study participants will receive Phexxi, the study drug. 8 pre-filled vaginal inserters with vaginal gel, Phexxi, will be provided to each of the participants with verbal and written instructions for application. Patients will be instructed to use Phexxi twice per week, on the same days every week.

0 / 5Eligibility criteria met