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

• Status: Unknown status
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Desogestrel; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Etonogestrel; NuvaRing; Polyestradiol phosphate

Criteria

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