Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
Information source: Eastern Virginia Medical School
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginosis, Bacterial
Intervention: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Eastern Virginia Medical School Official(s) and/or principal investigator(s):
Thomas D Kimble, MD, Principal Investigator, Affiliation: Eastern Virginia Medical School/CONRAD
Overall contact:
Julia Caul, Phone: 7574465808
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 NuvaRingĀ® use
2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic
concentration before and after treatment with NuvaRingĀ®
3. Monitor for changes in the Nugent score before and after NuvaRingĀ® use
4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRingĀ® use
5. Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRingĀ® 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.
Clinical Details
Official title: The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) after 3 months of NuvaRingĀ® use
Secondary outcome: Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRingĀ®
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Women (age 18 - 45) interested in using NuvaRingĀ® 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 BPā„140/ diastolic BPā„ 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 ā„ 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
Locations and Contacts
Julia Caul, Phone: 7574465808
Clinical Research Center at Eastern Virginia Medical School, Norfolk, Virginia 23507, United States; Recruiting
Julia Caul, Phone: 757-446-5808
Additional Information
Related publications: Iqbal SM, Kaul R. Mucosal innate immunity as a determinant of HIV susceptibility. Am J Reprod Immunol. 2008 Jan;59(1):44-54. Review. Valore EV, Park CH, Igreti SL, Ganz T. Antimicrobial components of vaginal fluid. Am J Obstet Gynecol. 2002 Sep;187(3):561-8. Fan SR, Liu XP, Liao QP. Human defensins and cytokines in vaginal lavage fluid of women with bacterial vaginosis. Int J Gynaecol Obstet. 2008 Oct;103(1):50-4. Epub 2008 Jul 16. John M, Keller MJ, Fam EH, Cheshenko N, Hogarty K, Kasowitz A, Wallenstein S, Carlucci MJ, Tuyama AC, Lu W, Klotman ME, Lehrer RI, Herold BC. Cervicovaginal secretions contribute to innate resistance to herpes simplex virus infection. J Infect Dis. 2005 Nov 15;192(10):1731-40. Epub 2005 Oct 13. Cherpes TL, Marrazzo JM, Cosentino LA, Meyn LA, Murray PJ, Hillier SL. Hormonal contraceptive use modulates the local inflammatory response to bacterial vaginosis. Sex Transm Infect. 2008 Feb;84(1):57-61. Epub 2007 Oct 2.
Starting date: October 2011
Last updated: April 23, 2012
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