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

Status unconfirmed · Phase 4

Conditions studied: Vaginosis, Bacterial

In brief

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.

Key facts

Study ID

NCT01448291

Run by

Eastern Virginia Medical School

People needed

30

Starts

2011-10-01

Expected to finish

2013-03-01

Last updated by the study team

2012-04-24

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)
• Women with a normal menstrual cycle (21-35 days) for the past three cycles
• Women with normal pelvic anatomy (by physical exam)
• Negative urine pregnancy test
• Normal pap smear within the past 12 months

You may not qualify if…

• Pregnancy
• Current breastfeeding
• Less than 6 weeks post partum
• Current IUD or Implanon use
• Depot Medroxyprogesterone Acetate use within the past 6 months
• Current diagnosis of uterine infection
• Use of hormonal contraception within the past 30 days
• Current cervical dysplasia
• Chronic immune suppression
• Chronic use of immune suppressors such as steroids
• Chronic antibiotic use
• Diabetes or fasting blood glucose >105
• Hysterectomy
• Uncontrolled hypertension (systolic BP≥140/ diastolic BP≥ 90)
• Migraine headaches complicated by aura or focal neurologic deficits
• Menopause
• Standard contraindications to combined oral contraceptive use (thrombophilia, active liver disease, active deep venous thrombosis, history of thrombosis)
• Use of tobacco products ≥ 35 years of age
• Two or more symptomatic genital herpes simplex virus (HSV) outbreaks in past 12 months
• Human immunodeficiency virus
• Vulvovaginal candidiasis
• Trichamonas vaginalis
• Neisseria gonorrhea
• Chlamydia trachomatis
• Bacterial vaginosis

Where it is running

• Clinical Research Center at Eastern Virginia Medical School — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.