Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception

Exclusion Criteria

• •1. Use of any hormonal or intrauterine contraceptive method within the past two months
• •2. Use of DMPA within the past 10 months
• •3. Any of the following within the past two months:
• •* Pregnancy or breastfeeding
• •* Surgery/biopsy of the vulva, vagina, or cervix
• •* History of STI
• •* New sexual partner
• •4. Evidence of vaginal/pelvic infection on screening
• •* Abnormal wet mount (see description above)
• •* Pelvic exam findings clinically consistent with infection
• •* Positive screen for Gc, Ct, or HIV (will be excluded post randomization)
• •5. Active HSV/ulcerative disease in the genital tract or perineum
• •6. History of immunosuppression (diabetes, HIV, chronic steroid use)
• •7. Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
• •8. Use of any systemic or vaginal steroid or antibiotic within the past 30 days
• •9. Vaginal or anal intercourse within 1 week of sample collection
• •10. Heterosexual vaginal intercourse since last menses without condom use
• •11. History of hysterectomy
• •12. History of malignancy in the uterus or cervix
• •13. Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
• •14. Allergy to copper and/or intolerance to levonorgestrel