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

NCT01240811 | Completed Results

• 1 other identifier: PRO09100199
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Genital Tract Mucosal Immunity; Genital Tract Microflora

Keywords

intrauterine device; IUD; levonorgestrel; copper; CD4; CCR5; microflora

Outcome Measures

Primary Outcomes (1)

• %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium

  Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety

  2 months

Secondary Outcomes (2)

• Change in Vaginal Flora

  2 Months

• Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis

  2 Months

Study Arms (3)

Control-No IUD

NO INTERVENTION

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

Levonorgestrel IUS

EXPERIMENTAL

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

Drug: IUD placement; Drug: Levonorgestrel IUD

Copper T380A IUD

EXPERIMENTAL

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

Drug: IUD placement; Drug: Copper T380A IUD

Interventions

IUD placement 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; Levonorgestrel IUS

Levonorgestrel IUD DRUG

Also known as: Mirena IUD

Levonorgestrel IUS

Copper T380A IUD DRUG

Also known as: ParaGard IUD

Copper T380A IUD

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharon Achilles: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Limitations and Caveats

We identified a need for methods optimization prior to proceeding with a large definitive study to determine contraceptive hormone induced changes in genital tract immune cell populations.

Results Point of Contact

• Title: Sharon Achilles, MD, PhD
• Organization: University of Pittsburgh

achisx@upmc.edu

412-641-1403

Study Officials

• Sharon Achilles, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 26, 2017
• Results First Posted: July 22, 2013

Record last verified: 2017-11

Locations

US (1)