Effects of a lactic acid gel on vaginal health
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
This study is testing if the contraceptive Phexxi can improve vaginal health by increasing good bacteria and reducing discomfort for women.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 54 Years |
| Sex | Female |
| Sponsor | Queen's Medical Center Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT05753813 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pre-menopausal women aged 18-54 with a history of recurrent bacterial vaginosis or candidiasis.
Not a fit: Patients who are pregnant, post-menopausal, or have certain medical conditions such as kidney disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of bacterial vaginosis and vulvovaginal candidiasis in women.
How similar studies have performed: While the approach of using Phexxi is novel, similar studies have shown promise in modifying the vaginal microbiome to improve health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Honolulu, Hawaii
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.