Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

January 5, 2014 updated by: Thomas Cherpes, DVM, MD
The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i.e., Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators will collect blood and genital tract samples from women before and after their initiation of a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Adolescent Clinic of Oakland

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 interested in initiating hormonal contraceptive use

Description

Inclusion Criteria:

  1. 15-25 years of age (inclusive)
  2. History of regular menstrual cycle
  3. Not pregnant
  4. No plan to become pregnant in the next 3 months
  5. Interested in beginning use of OC, DMPA, or LNG-IUD
  6. Able to read and provide written informed consent (and consent from a parent/guardian if the participant is a minor)

Exclusion Criteria:

  1. Anticipated move out of area that prevents return for a follow-up visit
  2. Unavailability for follow-up visit
  3. Less than 90 days post-partum or post-abortion
  4. Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
  5. Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
  6. DMPA injection less than 6 months prior to enrollment
  7. History of immunosuppressive condition of current use of immunosuppressive medications
  8. History of a cervical malignancy
  9. Detection of cervical anatomic pathologic conditions that preclude cervical biopsy procurement
  10. Intolerance or contradiction to use of OC, DMPA, or LNG-IUD

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
Intervention / Treatment
Depo-Provera
Women who choose to initiate Depo-Provera
Drug: Depo-Provera
Mirena
Women who choose to initiate Mirena (intrauterine device)
Drug: Mirena
Oral contraception
Women who choose to initiate oral contraception
Drug: Oral contraception

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proliferative capacity (i.e., ability to respond to antigen stimulation) of T cells isolated from the cervix of women before and after initiating a hormonal contraceptive
Time Frame: Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive
Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive

Collaborators and Investigators

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

Sponsor

Thomas Cherpes, DVM, MD

Collaborators

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

Investigators

  • Principal Investigator: Thomas L. Cherpes, MD, Assistant Professor

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

December 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 5, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO12010187
  • R01HD072663 (U.S. NIH Grant/Contract)

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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