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More info
You can access this
clinical trial
if you have
Vaginosis, Bacterial
and you are
between 18 and 45
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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.

Provided treatments

  • Drug: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01448291. The sponsor of the trial is Eastern Virginia Medical School and it is looking for 30 volunteers for the current phase.
Official trial title:
The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers