Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Thomas Cherpes, DVM, MD

Status: Terminated

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

Treatments: Drug: Mirena; Drug: Oral contraception; Drug: Depo-Provera

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01750476

R01HD072663 (U.S. NIH Grant/Contract)

PRO12010187

Details and patient eligibility

About

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).

Enrollment: 7 patients

Sex: Female

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

7 participants in 3 patient groups

Depo-Provera

Description:

Women who choose to initiate Depo-Provera

Treatment:

Drug: Depo-Provera

Mirena

Description:

Women who choose to initiate Mirena (intrauterine device)

Treatment:

Drug: Mirena

Oral contraception

Description:

Women who choose to initiate oral contraception

Treatment:

Drug: Oral contraception