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

NCT ID: NCT01240811

Last Updated: 2017-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Genital Tract Mucosal Immunity Genital Tract Microflora

Keywords

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intrauterine device IUD levonorgestrel copper CD4 CCR5 microflora

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control-No IUD

Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.

Group Type NO_INTERVENTION

No interventions assigned to this group

Levonorgestrel IUS

Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.

Group Type EXPERIMENTAL

IUD placement

Intervention Type DRUG

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).

Levonorgestrel IUD

Intervention Type DRUG

Copper T380A IUD

Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.

Group Type EXPERIMENTAL

IUD placement

Intervention Type DRUG

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).

Copper T380A IUD

Intervention Type DRUG

Interventions

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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).

Intervention Type DRUG

Levonorgestrel IUD

Intervention Type DRUG

Copper T380A IUD

Intervention Type DRUG

Other Intervention Names

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Mirena IUD ParaGard IUD

Eligibility Criteria

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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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sharon Achilles

OTHER

Sponsor Role lead

Responsible Party

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Sharon Achilles

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sharon Achilles, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO09100199

Identifier Type: -

Identifier Source: org_study_id