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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TERMINATED
120 participants
OBSERVATIONAL
2017-07-31
2018-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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No contraception/18-19 years old
No interventions assigned to this group
Use of ENG-I/18 - 19 years old
No interventions assigned to this group
LNG-IUS/18-19 years old
No interventions assigned to this group
No Contraception/ 25 - 45 years old
No interventions assigned to this group
Use of ENG-I/25 - 45 years old
No interventions assigned to this group
LNG-IUS/25-45 years old
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Adolescent aged 18-19
2. Adult aged 25-45
2. Meets one of the following contraception groups:
1. Regular menstrual cycles by participant history (if not using hormonal contraception)
2. Use of ENG-I (i.e. Implanon/Nexplanon) for at least 30 days by participant history
3. Use of LNG-IUS (Mirena or Skyla) for at least 30 days by participant history
3. HIV uninfected Note: HIV testing will be done as part of screening. However, if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the study visit.
4. Willing to undergo pelvic exam and collection of cervical biopsies
5. Willing to provided written informed consent
6. Agree to be sexually abstinent for 48 hours prior to the cervical biopsies and for one week after the biopsies.
Exclusion Criteria
2. Use of a diaphragm or spermicide for contraception
3. Pregnant or pregnancy within 90 days
4. Currently breastfeeding
5. Currently menstruating/bleeding (at time of specimen collection) Note: participant can return after cessation of bleeding for specimen collection
6. Past participation in more than one study involving cervical biopsies per participant report
7. Cervical biopsies within one month of specimen collection visit
8. Abnormal vaginal discharge or other genital tract symptoms at the time of specimen collection
9. Pelvic findings on the day of specimen collection consistent with cervicitis (i.e. MPC, erythema, edema) or anatomy making cervical biopsies difficult
10. Menopausal
11. Hysterectomy
12. History of malignancy of the genital tract (including cervix, uterus, vagina, and vulva)
13. History of immunosuppression (including HIV infection, diabetes, and chronic steroid use)
14. Known history of a platelet/bleeding/clotting disorder
15. Use of a systemic or vaginal antimicrobial agent within 7 days of specimen collection
16. Use of any vaginal product (i.e. douching, spermicide, lubricant) or device within 7 days of specimen collection Note: tampon use is acceptable
17. Any other condition that in the opinion of the Study Investigator would preclude provision of informed consent or make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
18 Years
45 Years
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Katherine Bunge
Assistant Professor
Principal Investigators
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Katherine Bunge, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO17050002
Identifier Type: -
Identifier Source: org_study_id
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