Modulation of Immunity by Hormonal Contraceptives

Thomas L. Cherpes

Status: Completed

Conditions: Contraception

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02011711

2013H0235

R01HD072663 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Mirena

Description:

Women interested in beginning use of Mirena

Depot-medroxyprogesterone acetate

Description:

Women interested in beginning use of depot-medroxyprogesterone acetate

Oral Contraception

Description:

Women interested in beginning use of oral contraception