Status:
UNKNOWN
Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Vaginosis, Bacterial
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 inflammati...
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 washin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Nugent scores of 4 or greater
- Use of any other study medication within the past 30 days
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01448291
Start Date
October 1 2011
End Date
March 1 2013
Last Update
April 24 2012
Active Locations (1)
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1
Clinical Research Center at Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507