Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Stopped early

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

In brief

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).

Key facts

Study ID

NCT01750476

Run by

Thomas Cherpes, DVM, MD

People needed

7

Starts

2012-12-01

Expected to finish

2013-06-01

Last updated by the study team

2014-01-07

Who can join

Age: 15 and older, up to 25. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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