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Effects of a one year reusable contraceptive vaginal ring on vaginal Microflora and the risk of vaginal infection: An open-label prospective evaluation

Huang, Y and Merkatz, RB and Hillier, SL and Roberts, K and Blithe, DL and Sitruk-Ware, R and Creinin, MD (2015) Effects of a one year reusable contraceptive vaginal ring on vaginal Microflora and the risk of vaginal infection: An open-label prospective evaluation. PLoS ONE, 10 (8).

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Abstract

Background A contraceptive vaginal ring (CVR) containing Nestorone® (NES) and ethinyl estradiol (EE) that is reusable for 1-year (13 cycles) is under development. This study assessed effects of this investigational CVR on the incidence of vaginal infections and change in vaginal microflora. Methods There were 120 women enrolled into a NES/EE CVR Phase III trial and a microbiology substudy for up to 1-year of cyclic product use. Gynecological examinations were conducted at baseline, the first week of cycle 6 and last week of cycle 13 (or during early discontinuation visits). Vaginal swabs were obtained for wet mount microscopy, Gram stain and culture. The CVR was removed from the vagina at the last study visit and cultured. Semi-quantitative cultures for Lactobacillus, Gardnerella vaginalis, Enterococcus faecalis, Staphylococcus aureus, Escherichia coli, anaerobic gram negative rods (GNRs), Candida albicans and other yeasts were performed on vaginal and CVR samples. Vaginal infections were documented throughout the study. Results Over 1-year of use, 3.3% of subjects were clinically diagnosed with bacterial vaginosis, 15.0% with vulvovaginal candidiasis, and 0.8% with trichomoniasis. The detection rate of these three infections did not change significantly from baseline to either Cycle 6 or 13. Nugent scores remained stable. H<inf>2</inf>O<inf>2</inf>-positive Lactobacillus dominated vaginal flora with a non-significant prevalence increase from 76.7%at baseline to 82.7% at cycle 6 and 90.2% at cycle 13, and a median concentration of 10<sup>7</sup> colony forming units (cfu) per gram. Although anaerobic GNRs prevalence increased significantly, the median concentration decreased slightly (10<sup>4</sup> to 10<sup>3</sup>cfu per gram). There were no significant changes in frequency or concentrations of other pathogens. High levels of agreement between vaginal and ring surface microbiota were observed. Conclusion Sustained use of the NES/EE CVR did not increase the risk of vaginal infection and was not disruptive to the vaginal ecosystem.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Huang, Y
Merkatz, RB
Hillier, SLslh6@pitt.eduSLH6
Roberts, K
Blithe, DL
Sitruk-Ware, R
Creinin, MD
Contributors:
ContributionContributors NameEmailPitt UsernameORCID
EditorLanday, AlanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Centers: Other Centers, Institutes, or Units > Magee-Women's Research Institute
Date: 12 August 2015
Date Type: Publication
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Journal or Publication Title: PLoS ONE
Volume: 10
Number: 8
DOI or Unique Handle: 10.1371/journal.pone.0134460
Institution: University of Pittsburgh
Schools and Programs: School of Medicine > Obstetrics, Gynecology, and Reproductive Sciences
Refereed: Yes
Date Deposited: 23 Aug 2016 14:28
Last Modified: 04 Feb 2019 15:58
URI: http://d-scholarship.pitt.edu/id/eprint/28398

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