Journal article
Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial
Journal of lower genital tract disease, Vol.24(3), pp.277-283
07/2020
DOI: 10.1097/LGT.0000000000000543
PMID: 32379102
Abstract
The aim of the study was to test the hypothesis that 5% monolaurin vaginal gel, a naturally occurring monoglyceride shown to have antimicrobial effects on vaginal pathogens without affecting Lactobacillus species, cures bacterial vaginosis (BV).
This was a multicenter, double-blinded, randomized controlled trial comparing 5% monolaurin vaginal gel to vehicle placebo (glycol-based) gel administered twice daily for 3 days. Nonpregnant, nonbreastfeeding women between ages 18 and 50 years were recruited and BV confirmed. Primary outcome was clinical cure assessed by resolution of all 4 Amsel criteria. Secondary outcomes included safety and tolerability assessed by solicited urogenital adverse events. Exploratory outcomes included colony counts for vaginal microbes associated with healthy vaginal flora (Lactobacillus species) and the dysbiosis often associated with BV (Gardnerella species and Mobiluncus species). A 2:1 test article to placebo randomization scheme was planned.
One hundred nine women participated with 73 randomized to the treatment arm and 36 to the placebo arm. There was no significant difference in clinical cure for BV (p = .42) with 17% of the monolaurin group and 25% of the placebo group achieving clinical cure. Lactobacilli species counts increased in the monolaurin group compared with placebo (1.0 × 10 vs -5.2 × 10). Two thirds of both groups reported solicited urogenital adverse events, but these were mild to moderate with no significant difference between groups (p = .24).
Monolaurin was no more clinically or microbiologically effective than placebo in curing BV. Future research should explore whether monolaurin may be used to increase Lactobacilli species.
Details
- Title: Subtitle
- Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial
- Creators
- Abigail C Mancuso - University of IowaLea E Widdice - Cincinnati Children's Hospital Medical CenterBrenna L Hughes - Duke UniversityPatrick Schlievert - University of IowaGeeta K Swamy - Duke UniversityColleen K Stockdale - University of IowaDavid I Bernstein - Cincinnati Children's Hospital Medical CenterPatricia L Winokur - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Journal of lower genital tract disease, Vol.24(3), pp.277-283
- DOI
- 10.1097/LGT.0000000000000543
- PMID
- 32379102
- ISSN
- 1089-2591
- eISSN
- 1526-0976
- Language
- English
- Date published
- 07/2020
- Academic Unit
- Microbiology and Immunology; Infectious Diseases; Obstetrics and Gynecology; Medicine Administration; Internal Medicine
- Record Identifier
- 9984318225802771
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