Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
Overview
- Phase
- Not Applicable
- Intervention
- Depo-Provera
- Conditions
- Initiation of Oral Contraception (OC)
- Sponsor
- Thomas Cherpes, DVM, MD
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
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).
Investigators
Thomas Cherpes, DVM, MD
Associate Professor
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •15-25 years of age (inclusive)
- •History of regular menstrual cycle
- •Not pregnant
- •No plan to become pregnant in the next 3 months
- •Interested in beginning use of OC, DMPA, or LNG-IUD
- •Able to read and provide written informed consent (and consent from a parent/guardian if the participant is a minor)
Exclusion Criteria
- •Anticipated move out of area that prevents return for a follow-up visit
- •Unavailability for follow-up visit
- •Less than 90 days post-partum or post-abortion
- •Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
- •Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
- •DMPA injection less than 6 months prior to enrollment
- •History of immunosuppressive condition of current use of immunosuppressive medications
- •History of a cervical malignancy
- •Detection of cervical anatomic pathologic conditions that preclude cervical biopsy procurement
- •Intolerance or contradiction to use of OC, DMPA, or LNG-IUD
Arms & Interventions
Depo-Provera
Women who choose to initiate Depo-Provera
Intervention: Depo-Provera
Mirena
Women who choose to initiate Mirena (intrauterine device)
Intervention: Mirena
Oral contraception
Women who choose to initiate oral contraception
Intervention: Oral contraception
Outcomes
Primary Outcomes
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