Status:
COMPLETED
Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
Lead Sponsor:
Sharon Achilles
Conditions:
Genital Tract Mucosal Immunity
Genital Tract Microflora
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and...
Eligibility Criteria
Inclusion
- Non-pregnant, healthy females who are seeking an IUD for contraception
- Age 18-40 years, inclusive at the time of enrollment
- 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
- Willing and able to sign the informed consent and to comply with the study protocol
- Inclusion criteria for healthy control subjects:
- Non-pregnant, healthy females
- Age 18-40 years, inclusive at the time of enrollment
- 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
- Willing and able to sign the informed consent and to comply with the study protocol
- Prior surgical sterilization or heterosexually abstinent
Exclusion
- Use of any hormonal or intrauterine contraceptive method within the past two months
- Use of DMPA within the past 10 months
- 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
- 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)
- Active HSV/ulcerative disease in the genital tract or perineum
- History of immunosuppression (diabetes, HIV, chronic steroid use)
- Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
- Use of any systemic or vaginal steroid or antibiotic within the past 30 days
- Vaginal or anal intercourse within 1 week of sample collection
- Heterosexual vaginal intercourse since last menses without condom use
- History of hysterectomy
- History of malignancy in the uterus or cervix
- Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
- Allergy to copper and/or intolerance to levonorgestrel
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01240811
Start Date
November 1 2010
End Date
November 1 2011
Last Update
December 26 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213