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Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Initiation of Oral Contraception (OC); Initiation of Depo-Provera (DMPA); Initiation of Mirena (LNG-IUD)

Intervention: Mirena (Drug); Oral contraception (Drug); Depo-Provera (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Thomas Cherpes, DVM, MD

Official(s) and/or principal investigator(s):
Thomas L. Cherpes, MD, Principal Investigator, Affiliation: assistant professor


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).

Clinical Details

Official title: Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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


Minimum age: 15 Years. Maximum age: 25 Years. Gender(s): Female.


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

Locations and Contacts

UPMC Adolescent Clinic of Oakland, Pittsburgh, Pennsylvania 15213, United States
Additional Information

Cherpes Research Group

Related publications:

Vicetti Miguel RD, Hendricks RL, Aguirre AJ, Melan MA, Harvey SA, Terry-Allison T, St Leger AJ, Thomson AW, Cherpes TL. Dendritic cell activation and memory cell development are impaired among mice administered medroxyprogesterone acetate prior to mucosal herpes simplex virus type 1 infection. J Immunol. 2012 Oct 1;189(7):3449-61. Epub 2012 Aug 31.

Vicetti Miguel RD, Maryak SA, Cherpes TL. Brefeldin A, but not monensin, enables flow cytometric detection of interleukin-4 within peripheral T cells responding to ex vivo stimulation with Chlamydia trachomatis. J Immunol Methods. 2012 Oct 31;384(1-2):191-5. doi: 10.1016/j.jim.2012.07.018. Epub 2012 Jul 29.

Starting date: December 2012
Last updated: January 5, 2014

Page last updated: August 23, 2015

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