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OpenTrials
Completed

NCT Number: NCT02011711

Modulation of Immunity by Hormonal Contraceptives

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

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Key information

Conditions

Age range

15 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Edwards Building

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in ectocervical permeability

    Time frame: Baseline and 1 month

Sponsors and collaborators

Lead sponsor

Thomas L. Cherpes

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2013
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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