RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-15
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05753813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 54 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-54
  2. * Female
  3. * Pre-menopausal
  4. * Can speak and read in English
  5. * Displays capacity for informed consent
  6. * 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
  1. * Pregnant or trying to become pregnant
  2. * Post-menopausal
  3. * Using NuvaRing device
  4. * A past medical history of kidney disease, recurrent UTI, and/or urinary tract abnormalities
  5. * Current UTI
  6. * Using Phexxi as a contraceptive during the collection period of the study

Contacts and Locations

Study Contact

Olivia H Manayan, MD, MPH
CONTACT
808-348-7859
omanayan@hawaii.edu

Principal Investigator

Olivia Manayan, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Hawaii
Bliss Kaneshiro, MD, MPH
PRINCIPAL_INVESTIGATOR
Queen's Medical Center
Corrie Miller, DO
PRINCIPAL_INVESTIGATOR
University of Hawaii

Study Locations (Sites)

Queens Medical Center, 1004 Clinic POB1
Honolulu, Hawaii, 96813
United States

Collaborators and Investigators

Sponsor: Queen's Medical Center

  • Olivia Manayan, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Hawaii
  • Bliss Kaneshiro, MD, MPH, PRINCIPAL_INVESTIGATOR, Queen's Medical Center
  • Corrie Miller, DO, PRINCIPAL_INVESTIGATOR, University of Hawaii

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-15
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Bacterial Vaginosis
  • Vulvovaginal Candidiasis