Initiation of Depo-Provera (DMPA) Clinical Trial
Official title:
Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
| Verified date | January 2014 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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).
| Status | Terminated |
| Enrollment | 7 |
| Est. completion date | June 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 15 Years to 25 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | UPMC Adolescent Clinic of Oakland | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Thomas Cherpes, DVM, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |