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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01240811
First received: November 11, 2010
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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 cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).

Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.

The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.


Condition Intervention
Genital Tract Mucosal Immunity
Genital Tract Microflora
 Drug: IUD placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Immune cell populations [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    CD4 cells and CCR5 surface receptors as measured by flow cytomety


Secondary Outcome Measures:
  • vaginal and endometrial flora [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
    Changes in vaginal and endometrial flora as assessed by qualitative and quantitative culture


Enrollment: 42
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control-No IUD
Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Experimental: Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
 Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).
Experimental: Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
 Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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

Inclusion criteria for healthy control subjects:

  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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240811

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon Achilles, MD, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Sharon Achilles, assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01240811     History of Changes
Other Study ID Numbers: PRO09100199
Study First Received: November 11, 2010
Last Updated: December 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
intrauterine device
IUD
levonorgestrel
copper
 CD4
CCR5
microflora

Additional relevant MeSH terms:
Copper
Levonorgestrel
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 22, 2013