Clinical trial NCT01240811: Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
Official title: Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Tract Mucosal Immunity
Genital Tract Microflora
Keywords: intrauterine device
IUD
levonorgestrel
copper
CD4
CCR5
microflora
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
timeFrame: 2 months
Secondary outcomes:
measure: Change in Vaginal Flora
timeFrame: 2 Months
measure: Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis
timeFrame: 2 Months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon Achilles, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: