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

April 23, 2012 updated by: Thomas Kimble, Eastern Virginia Medical School

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Julia Caul
  • Phone Number: 7574465808

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Clinical Research Center at Eastern Virginia Medical School
        • Contact:
          • Julia Caul
          • Phone Number: 757-446-5808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women (age 18 - 45) interested in using NuvaRing® for contraception for 3 or more months, and women who are not at risk for pregnancy (i.e. abstinent, tubal sterilization, partner with vasectomy)
  2. Women with a normal menstrual cycle (21-35 days) for the past three cycles
  3. Women with normal pelvic anatomy (by physical exam)
  4. Negative urine pregnancy test
  5. Normal pap smear within the past 12 months

Exclusion Criteria:

  1. Pregnancy
  2. Current breastfeeding
  3. Less than 6 weeks post partum
  4. Current IUD or Implanon use
  5. Depot Medroxyprogesterone Acetate use within the past 6 months
  6. Current diagnosis of uterine infection
  7. Use of hormonal contraception within the past 30 days
  8. Current cervical dysplasia
  9. Chronic immune suppression
  10. Chronic use of immune suppressors such as steroids
  11. Chronic antibiotic use
  12. Diabetes or fasting blood glucose >105
  13. Hysterectomy
  14. Uncontrolled hypertension (systolic BP≥140/ diastolic BP≥ 90)
  15. Migraine headaches complicated by aura or focal neurologic deficits
  16. Menopause
  17. Standard contraindications to combined oral contraceptive use (thrombophilia, active liver disease, active deep venous thrombosis, history of thrombosis)
  18. Use of tobacco products ≥ 35 years of age
  19. Two or more symptomatic genital herpes simplex virus (HSV) outbreaks in past 12 months
  20. Human immunodeficiency virus
  21. Vulvovaginal candidiasis
  22. Trichamonas vaginalis
  23. Neisseria gonorrhea
  24. Chlamydia trachomatis
  25. Bacterial vaginosis
  26. Nugent scores of 4 or greater
  27. Use of any other study medication within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nuvaring
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 Names:
  • NuvaRing®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing®
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Thomas D Kimble, MD, Eastern Virginia Medical School/CONRAD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-NVR11
  • 11-01-FB-0003 (Other Identifier: EVMS IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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