Modulation of Immunity by Hormonal Contraceptives

Completed

• Conditions: Contraception

• Registration Number: NCT02011711
• Lead Sponsor: Thomas L. Cherpes

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ectocervical permeability	Baseline and 1 month

Trial Locations

Locations (1)

Edwards Building; 🇺🇸 Stanford, California, United States