NCT01240811

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

Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Sharon Achilles · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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).
DRUG	Levonorgestrel IUD
DRUG	Copper T380A IUD

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-11-15
• Last updated: 2017-12-26
• Results posted: 2013-07-22

Locations

1 site across 1 country: United States