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Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial.

Publication ,  Journal Article
Mancuso, AC; Widdice, LE; Hughes, BL; Schlievert, P; Swamy, GK; Stockdale, CK; Bernstein, DI; Winokur, PL
Published in: J Low Genit Tract Dis
July 2020

OBJECTIVE: 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). MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Duke Scholars

Published In

J Low Genit Tract Dis

DOI

EISSN

1526-0976

Publication Date

July 2020

Volume

24

Issue

3

Start / End Page

277 / 283

Location

United States

Related Subject Headings

  • Young Adult
  • Vaginosis, Bacterial
  • Vaginal Creams, Foams, and Jellies
  • Treatment Outcome
  • Placebos
  • Obstetrics & Reproductive Medicine
  • Monoglycerides
  • Middle Aged
  • Laurates
  • Humans
 

Citation

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Mancuso, A. C., Widdice, L. E., Hughes, B. L., Schlievert, P., Swamy, G. K., Stockdale, C. K., … Winokur, P. L. (2020). Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial. J Low Genit Tract Dis, 24(3), 277–283. https://doi.org/10.1097/LGT.0000000000000543
Mancuso, Abigail C., Lea E. Widdice, Brenna L. Hughes, Patrick Schlievert, Geeta K. Swamy, Colleen K. Stockdale, David I. Bernstein, and Patricia L. Winokur. “Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial.J Low Genit Tract Dis 24, no. 3 (July 2020): 277–83. https://doi.org/10.1097/LGT.0000000000000543.
Mancuso AC, Widdice LE, Hughes BL, Schlievert P, Swamy GK, Stockdale CK, et al. Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial. J Low Genit Tract Dis. 2020 Jul;24(3):277–83.
Mancuso, Abigail C., et al. “Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial.J Low Genit Tract Dis, vol. 24, no. 3, July 2020, pp. 277–83. Pubmed, doi:10.1097/LGT.0000000000000543.
Mancuso AC, Widdice LE, Hughes BL, Schlievert P, Swamy GK, Stockdale CK, Bernstein DI, Winokur PL. Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial. J Low Genit Tract Dis. 2020 Jul;24(3):277–283.

Published In

J Low Genit Tract Dis

DOI

EISSN

1526-0976

Publication Date

July 2020

Volume

24

Issue

3

Start / End Page

277 / 283

Location

United States

Related Subject Headings

  • Young Adult
  • Vaginosis, Bacterial
  • Vaginal Creams, Foams, and Jellies
  • Treatment Outcome
  • Placebos
  • Obstetrics & Reproductive Medicine
  • Monoglycerides
  • Middle Aged
  • Laurates
  • Humans