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Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01750476
Enrollment
7
Registered
2012-12-17
Start date
2012-12-31
Completion date
2013-06-30
Last updated
2014-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

oral contraception, Depo-Provera, Mirena

Brief 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).

Interventions

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Thomas Cherpes, DVM, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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 contraceptivePrior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026