Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
This study is currently recruiting participants.
Verified December 2012 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01750476
First received: December 10, 2012
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Initiation of Oral Contraception (OC) Initiation of Depo-Provera (DMPA) Initiation of Mirena (LNG-IUD) |
Drug: Mirena Drug: Oral contraception Drug: Depo-Provera |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- 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 [ Time Frame: Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Depo-Provera
Women who choose to initiate Depo-Provera
|
Drug: Depo-Provera |
|
Mirena
Women who choose to initiate Mirena (intrauterine device)
|
Drug: Mirena |
|
Oral contraception
Women who choose to initiate oral contraception
|
Drug: Oral contraception |
Eligibility| Ages Eligible for Study: | 15 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Women interested in initiating hormonal contraceptive use
Criteria
Inclusion Criteria:
- 15-25 years of age (inclusive)
- History of regular menstrual cycle
- Not pregnant
- No plan to become pregnant in the next 3 months
- Interested in beginning use of OC, DMPA, or LNG-IUD
- Able to read and provide written informed consent (and consent from a parent/guardian if the participant is a minor)
Exclusion Criteria:
- Anticipated move out of area that prevents return for a follow-up visit
- Unavailability for follow-up visit
- Less than 90 days post-partum or post-abortion
- Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
- Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
- DMPA injection less than 6 months prior to enrollment
- History of immunosuppressive condition of current use of immunosuppressive medications
- History of a cervical malignancy
- Detection of cervical anatomic pathologic conditions that preclude cervical biopsy procurement
- Intolerance or contradiction to use of OC, DMPA, or LNG-IUD
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750476
Contacts
| Contact: Thomas L. Cherpes, MD | 412 692 9563 | cherpestl@upmc.edu |
Locations
| United States, Pennsylvania | |
| UPMC Adolescent Clinic of Oakland | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Barb Cardinal Busse, MSN 412-692-8504 Barb.CardinalBusse@chp.edu | |
| Principal Investigator: Thomas L Cherpes, MD | |
| Sub-Investigator: Aletha Akers, MD | |
| Sub-Investigator: Barb Cardinal Busse, MSN | |
| Sub-Investigator: Gina Sucato, MD | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Principal Investigator: | Thomas L. Cherpes, MD | assistant professor |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01750476 History of Changes |
| Other Study ID Numbers: | PRO12010187, R01HD072663 |
| Study First Received: | December 10, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
oral contraception Depo-Provera Mirena |
Additional relevant MeSH terms:
|
Levonorgestrel Medroxyprogesterone Medroxyprogesterone Acetate Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013