Modulation of Immunity by Hormonal Contraceptives

N/ACompletedNCT02011711

Thomas L. Cherpes90 enrolled

Overview

Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).

Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Contraception

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * not pregnant * regular menstrual cycle Exclusion Criteria: * use of oral contraceptive or Mirena in 3 months prior to enrollment * use of depot-medroxyprogesterone acetate in 6 months prior to enrollment * diagnosis of sexually transmitted infection in 30 days prior to enrollment * history of cervical malignancy

Locations (1)

Edwards Building

Stanford, California, United States

Outcomes

Primary Outcomes

Change in ectocervical permeability

Time frame: Baseline and 1 month

Data from ClinicalTrials.gov

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