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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Eastern Virginia Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Kimble, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01448291
First received: July 8, 2011
Last updated: April 23, 2012
Last verified: April 2012
  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.


Condition Intervention Phase
Vaginosis, Bacterial
Drug: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing® [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
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 Name: NuvaRing®

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448291

Contacts
Contact: Julia Caul 7574465808

Locations
United States, Virginia
Clinical Research Center at Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
Contact: Julia Caul    757-446-5808      
Sponsors and Collaborators
Eastern Virginia Medical School
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Thomas D Kimble, MD Eastern Virginia Medical School/CONRAD
  More Information

Publications:
Responsible Party: Thomas Kimble, Assistant Professor, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01448291     History of Changes
Other Study ID Numbers: CRC-NVR11, 11-01-FB-0003
Study First Received: July 8, 2011
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
Contraception
Nuvaring
Vaginal inflammation
Bacterial vaginosis
Nugent score

Additional relevant MeSH terms:
Vaginitis
Vaginosis, Bacterial
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female
Contraceptive Agents
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
3-keto-desogestrel
Desogestrel
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins

ClinicalTrials.gov processed this record on August 21, 2014