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Acidifying Agent

Study group for Bacterial Vaginosis

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
Female
Pre-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

Study Summary

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

Eligible Conditions
  • Bacterial Vaginosis
  • Vaginal Yeast Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are a woman.
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You are not yet in menopause.
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You are able to understand the study and give consent to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after baseline vaginal swab collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after baseline vaginal swab collection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
To assess patient satisfaction/acceptability of this intervention as a therapeutic/prophylactic agent for recurrent vulvovaginitis

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.

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Who is running the clinical trial?

Queen's Medical CenterLead Sponsor
21 Previous Clinical Trials
4,840 Total Patients Enrolled
University of Hawaii FoundationUNKNOWN
Olivia Manayan, MD, MPHPrincipal InvestigatorUniversity of Hawaii

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a possibility for me to partake in this medical research?

"This clinical trial has restricted eligibility to women between 18 and 54 suffering from bacterial vaginosis, with a quota of 22 enrollees."

Answered by AI

Is the age threshold for participation in this trial below eighty years of age?

"The upper bound of eligibility for this trial is 54 years old, while the lower limit is 18."

Answered by AI

What is the total enrollment capacity of this experiment?

"Confirmed. According to clinicaltrials.gov, this medical study is currently recruiting participants, having been initially uploaded on February 27th 2023 and revised most recently on February 22nd 2023. This trial has a goal of enrolling 22 individuals from one site."

Answered by AI

Is this research endeavor currently enrolling participants?

"Clinicaltrials.gov reports that this experiment is recruiting patients at the time of writing; the trial was initially posted on February 27th 2023 and recently modified on February 22nd 2023."

Answered by AI
~11 spots leftby Mar 2025