Vaginosis, Bacterial Clinical Trial
Official title:
The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers
It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of
inflammation.
Hypothesis:
The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as
vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in
the vagina.
Specific aims of this study are to:
1. Determine biomarkers of inflammation, including defensins and cytokines, concentrations
in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use
2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic
concentration before and after treatment with NuvaRing®
3. Monitor for changes in the Nugent score before and after NuvaRing® use
4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use
5. Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use
Methods This is a prospective, open-label, nonrandomized study. Participants will serve as
their own controls. The Clinical Research Center of Eastern Virginia Medical School,
Norfolk, Virginia, U.S.A. will be the only study site.
1. To complete specific aim #1, the investigators will use commercially available elisa
kits to measure human defensins, inflammatory cytokines, and anti-inflammatory
cytokines in vaginal fluid washings collected before and after use of NuvaRing.
2. To complete specific aim #2, the investigators will collect biopsies of the uterine
cervix before and after NuvaRing use. Specimens will undergo histopathological measures
for overall appearance, epithelial integrity, epithelial thickness, leukocyte
infiltration, congestion, and edema. The investigators will quantitate the number of
CD45+ and NFkB+ cells using immunohistology in the cervical epithelium.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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