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Clinical trial

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

ID
Name
RA-2022-015
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.
Trial arms
Trial start
2023-02-27
Estimated PCD
2023-06-30
Trial end
2023-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Phexxi
intravaginal gel twice weekly for 4 weeks.
Arms:
Study group
Size
22
Primary endpoint
To assess participant's baseline vaginal microbiome makeup
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
30 days after baseline vaginal swab collection
To assess if the use of Phexxi causes changes in the vaginal microbiome
60 days after baseline vaginal swab collection
To assess participant's baseline vulvovaginitis symptoms
On day of recruitment to the study
To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants
30 days after baseline vaginal swab collection
To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants
60 days after baseline vaginal swab collection
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ESTIMATED'}}
Updated at
2023-03-03

1 organization

1 product

2 indications

Organization
Queen's Medical Center
Product
Phexxi
Indication
Bacterial Vaginosis
Indication
Vulvovaginal Candidiasis