Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Depo-Provera

Women who choose to initiate Depo-Provera

Depo-Provera

Intervention Type DRUG

Mirena

Women who choose to initiate Mirena (intrauterine device)

Mirena

Intervention Type DRUG

Oral contraception

Women who choose to initiate oral contraception

Oral contraception

Intervention Type DRUG

Interventions

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Mirena

Intervention Type DRUG

Oral contraception

Intervention Type DRUG

Depo-Provera

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes