N/A Completed N=42 Randomized Basic Science

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

Genital Tract Mucosal Immunity · Genital Tract Microflora

Source: ClinicalTrials.gov NCT01240811 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcomePrimary: %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium — 4.9; 11.7; 7.2 % of T-cells expressing CCR5 — p=0.80

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium	4.9; 11.7; 7.2	0.80
SECONDARY Change in Vaginal Flora	0; 1; 0	0.08
SECONDARY Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis	-0.6; -0.1; 0.1; 0; 0; 0	0.46

Eligibility Criteria

Inclusion Criteria

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

Inclusion criteria for healthy control subjects:

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

Exclusion Criteria

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
Vaginal or anal intercourse within 1 week of sample collection
Heterosexual vaginal intercourse since last menses without condom use
History of hysterectomy
History of malignancy in the uterus or cervix
Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
Allergy to copper and/or intolerance to levonorgestrel

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01240811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.