Modulation of Immunity by Hormonal Contraceptives

January 12, 2017 updated by: Thomas L. Cherpes

Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Edwards Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women seeking to initiate use of an oral contraceptive, depot-medroxyprogesterone acetate, or Mirena.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mirena
Women interested in beginning use of Mirena
Depot-medroxyprogesterone acetate
Women interested in beginning use of depot-medroxyprogesterone acetate
Oral Contraception
Women interested in beginning use of oral contraception

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ectocervical permeability
Time Frame: Baseline and 1 month
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas L. Cherpes

Collaborators

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

Investigators

  • Principal Investigator: Thomas L Cherpes, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2013H0235
  • R01HD072663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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