Vaginosis, Bacterial
Conditions
Keywords
Contraception, Nuvaring, Vaginal inflammation, Bacterial vaginosis, Nugent score
Brief 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 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.
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.
Interventions
DRUGEtonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring
Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months
Sponsors
Merck Sharp & Dohme LLC
Eastern Virginia Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing® | Baseline and 3 months |
Countries
United States
Contacts
Primary ContactJulia Caul
Outcome results
None listed