Abstract
5% Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized, Placebo-Controlled Trial [23J]
Obstetrics and gynecology (New York. 1953), Vol.133 Suppl 1(1), pp.143S-143S
05/2019
DOI: 10.1097/01.AOG.0000558839.33387.d5
Abstract
INTRODUCTION:Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge and standard medical treatment is associated with a high recurrence rate. Monolaurin has antimicrobial effects on vaginal pathogens without affecting lactobacilli sp. We assessed the effectiveness and safety of 5% Monolaurin vaginal gel for treatment of BV.
METHODS:This multicenter, double-blinded, randomized trial compared 5% Monolaurin vaginal gel to vehicle placebo gel self-administered twice daily for three days. Healthy, non-pregnant, non-breastfeeding women ages 18 to 50 with BV diagnosed by Amsel criteria were enrolled and randomized 2 to 1 (Monolaurin to placebo). The Modified Intent To Treat (mITT) population had Nugent Scores ≥4. Clinical efficacy was defined as resolution of all four Amsel Criteria and therapeutic cure as Nugent Score ≤ 3. Solicited urogenital symptoms and adverse events were collected.
RESULTS:109 women participated, with 73 randomized to treatment arm and 36 to placebo arm. Although lactobacilli sp. counts increased in the Monolaurin group compared to placebo (1.0x10^7 vs -5.2x10^6), there was no significant difference in achieving clinical cure (P=.42) or therapeutic cure (P=.99) with only 17% of the Monolaurin group and 25% of the placebo group achieving clinical cure, and only 3% of both groups achieving therapeutic cure (mITT population). There was no difference between groups in solicited urogenital symptoms (P=.24) and all were mild to moderate in nature. No serious adverse events were reported.
CONCLUSION:Short course 5% Monolaurin was well tolerated but no more effective than placebo in curing BV; however, longer courses should be evaluated.
Details
- Title: Subtitle
- 5% Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized, Placebo-Controlled Trial [23J]
- Creators
- Abigail Mancuso - University of IowaLea WiddiceBrenna HughesColleen StockdaleDavid BernsteinPatricia Winokur
- Resource Type
- Abstract
- Publication Details
- Obstetrics and gynecology (New York. 1953), Vol.133 Suppl 1(1), pp.143S-143S
- Publisher
- by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved
- DOI
- 10.1097/01.AOG.0000558839.33387.d5
- ISSN
- 0029-7844
- eISSN
- 1873-233X
- Language
- English
- Date published
- 05/2019
- Academic Unit
- Infectious Diseases; Internal Medicine; Medicine Administration; Obstetrics and Gynecology
- Record Identifier
- 9984316892102771
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