Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Study Overview
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Brief Summary
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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).

Official Title
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Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Conditions
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Initiation of Oral Contraception (OC), Initiation of Depo-Provera (DMPA), Initiation of Mirena (LNG-IUD)

Intervention / Treatment
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* Drug: Mirena
* Drug: Oral contraception
* Drug: Depo-Provera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Depo-Provera<br>Women who choose to initiate Depo-Provera | Drug: Depo-Provera<br> <br> |
| Mirena<br>Women who choose to initiate Mirena (intrauterine device) | Drug: Mirena<br> <br> |
| Oral contraception<br>Women who choose to initiate oral contraception | Drug: Oral contraception<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Prior to and   1 month (but up to 2 months) after initiation of a hormonal contraceptive | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral contraception, Depo-Provera, Mirena