Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01448291|
Recruitment Status : Unknown
Verified April 2012 by Thomas Kimble, Eastern Virginia Medical School.
Recruitment status was: Recruiting
First Posted : October 7, 2011
Last Update Posted : April 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Vaginosis, Bacterial||Drug: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||March 2013|
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®
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|