Vaginosis, Bacterial Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Center at Eastern Virginia Medical School | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Eastern Virginia Medical School | Merck Sharp & Dohme Corp. |
United States,
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. — View Citation
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. doi: 10.1016/j.ijgo.2008.05.020. Epub 2008 Jul 16. — View Citation
Iqbal SM, Kaul R. Mucosal innate immunity as a determinant of HIV susceptibility. Am J Reprod Immunol. 2008 Jan;59(1):44-54. Review. — View Citation
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. — View Citation
Valore EV, Park CH, Igreti SL, Ganz T. Antimicrobial components of vaginal fluid. Am J Obstet Gynecol. 2002 Sep;187(3):561-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months | Yes | |
Secondary | Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing® | Baseline and 3 months | Yes |
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