Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Terminated

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

• Registration Number: NCT01750476
• Lead Sponsor: Thomas Cherpes, DVM, MD

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-05
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral contraception	Oral contraception	Women who choose to initiate oral contraception
Depo-Provera	Depo-Provera	Women who choose to initiate Depo-Provera
Mirena	Mirena	Women who choose to initiate Mirena (intrauterine device)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UPMC Adolescent Clinic of Oakland; 🇺🇸 Pittsburgh, Pennsylvania, United States