Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sharon Achilles
Age
18–40
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
1. Non-pregnant, healthy females who are seeking an IUD for contraception
2. Age 18-40 years, inclusive at the time of enrollment
3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
4. Willing and able to sign the informed consent and to comply with the study protocol
1. Non-pregnant, healthy females
2. Age 18-40 years, inclusive at the time of enrollment
3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
4. Willing and able to sign the informed consent and to comply with the study protocol
5. Prior surgical sterilization or heterosexually abstinent
You may not be if
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
Clareo Health | Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
