Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives



Status:Recruiting
Healthy:No
Age Range:15 - 25
Updated:1/1/2014
Start Date:December 2012
End Date:January 2017
Contact:Thomas L. Cherpes, MD
Email:cherpestl@upmc.edu
Phone:412 692 9563

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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).


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
We found this trial at
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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