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

NCT05753813 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: RA-2022-015
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Vaginosis; Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (6)

• To assess participant's baseline vaginal microbiome makeup

  NextGen analysis pre-intervention

  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

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

  NextGen analysis immediately post-intervention

  30 days after baseline vaginal swab collection

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

  NextGen analysis 30 days post-completion of intervention

  60 days after baseline vaginal swab collection

• To assess participant's baseline vulvovaginitis symptoms

  Survey to be completed pre-intervention

  On day of recruitment to the study

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

  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.

  30 days after baseline vaginal swab collection

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

  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.

  60 days after baseline vaginal swab collection

Secondary Outcomes (1)

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

  30 and 60 days after baseline swab collection

Study Arms (1)

Study group

EXPERIMENTAL

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.

Drug: Phexxi

Interventions

Phexxi DRUG

intravaginal gel twice weekly for 4 weeks.

Study group

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• Queen's Medical Center: lead
• University of Hawaii Foundation: collaborator

Study Sites (1)

Queens Medical Center, 1004 Clinic POB1

Honolulu, Hawaii, 96813, United States

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial; Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Study Officials

• Olivia Manayan, MD, MPH

  University of Hawaii

  PRINCIPAL INVESTIGATOR

• Bliss Kaneshiro, MD, MPH

  Queen's Medical Center

  PRINCIPAL INVESTIGATOR

• Corrie Miller, DO

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia H Manayan, MD, MPH

CONTACT

808-348-7859; omanayan@hawaii.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGY-2, University of Hawaii Ob/Gyn Residency

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: March 3, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)