Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
Recruitment status was: Recruiting
It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of inflammation.
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:
- Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use
- Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration before and after treatment with NuvaRing®
- Monitor for changes in the Nugent score before and after NuvaRing® use
- Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use
- 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.
|Vaginosis, Bacterial||Drug: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers|
- Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) after 3 months of NuvaRing® use [ Time Frame: 3 months ]
- Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing® [ Time Frame: Baseline and 3 months ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
This is a single-group study in which data points after use of the etonogestrel/ethinyl estradiol vaginal ring will be compared to baseline.
Drug: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring
Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months
Other Name: NuvaRing®
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448291
|Contact: Julia Caul||7574465808|
|United States, Virginia|
|Clinical Research Center at Eastern Virginia Medical School||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: Julia Caul 757-446-5808|
|Principal Investigator:||Thomas D Kimble, MD||Eastern Virginia Medical School/CONRAD|