Quantification of Immune Cells in Women Using Contraception (CHIC II)
NCT ID: NCT01873170
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
326 participants
OBSERVATIONAL
2013-08-31
2020-10-31
Brief Summary
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Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women who are not using birth control and who are not at risk of pregnancy for comparison.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Combined Oral Contraceptive pills
Levonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs
levonorgestrel exposure
depot medroxyprogesterone acetate
150mg DMPA intramuscular injection once every 3 months
DMPA exposure
Levonorgestrel-intrauterine device
52mg levonorgestrel intrauterine device
levonorgestrel exposure
IUD insertion
Copper intrauterine device
Copper T380A intrauterine device
IUD insertion
Etonogestrel contraceptive implant
68mg etonogestrel subdermal implant
etonogestrel exposure
subdermal contraceptive implant insertion
Control
Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use
No interventions assigned to this group
Interventions
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levonorgestrel exposure
DMPA exposure
etonogestrel exposure
IUD insertion
subdermal contraceptive implant insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Non-pregnant women in general good health as determined by the site clinician
3. Premenopausal with history of regular menstrual cycles (regular 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. Women enrolling into the control group only: Regular and consistent condom use, prior surgical sterilization by participant or sexual partner, or heterosexually abstinent for entire study participation
5. Able and willing to provide written informed consent to be screened for and to take part in the study. Including willingness to undergo all study-related assessments and follow all study-related procedures
6. Able and willing to provide adequate locator information
7. HIV-uninfected based on testing performed by study staff at screening (per HIV testing algorithm in Appendices I)
8. At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial
Exclusion Criteria
2. Use of DMPA within 10 months of enrollment
3. Pregnancy or breastfeeding within 60 days of enrollment
4. Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and endometrium)
5. Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms, menstrual collection devices, and pessaries; excludes tampons and condoms) or product (includes N9, microbicide, douche, antifungal, steroid, or hormone) in the 30 days prior to enrollment
6. New sexual partner within 90 days of enrollment
7. Urogenital infection or suspected infection within 30 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhea, C. trachomatis, or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: seropositive HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or NGU
8. Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use)
9. Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
10. Menses or other vaginal bleeding at the time of Enrollment\* (\*Women who have vaginal bleeding at the scheduled Enrollment Visit may return at a different date to be re-examined and possibly enrolled provided they are still within the 90-day screening window and meet all criteria).
11. Vaginal or anal intercourse within 36 hours prior to enrollment
12. Heterosexual intercourse since last menses that places the participant at risk of pregnancy (without condom use or sterilization of at least one partner)
13. History of hysterectomy
14. History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
15. Contraindication, allergy or intolerance to use of the contraceptive desired by the participant
16. Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
18 Years
34 Years
FEMALE
Yes
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Sharon Achilles
Assistant Professor
Principal Investigators
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Beatrice Chen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Center for Family Planning Research
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY19100126
Identifier Type: -
Identifier Source: org_study_id