Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thomas Cherpes, DVM, MD
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Contraceptive Agents; Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

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