Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- Thomas L. Cherpes
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in ectocervical permeability
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).
Detailed Description
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.
Investigators
Thomas L. Cherpes
Assistant Professor
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in ectocervical permeability
Time Frame: Baseline and 1 month