NCT01448291

Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers

The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vaginosis, Bacterial

Interventions

Type	Name	Description
DRUG	Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring	Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-10-01
• Completion: 2013-03-01
• First posted: 2011-10-07
• Last updated: 2012-04-24

Locations

1 site across 1 country: United States