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Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

This study has been terminated.
(PI and lab have re-located study to The Ohio State University)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Cherpes, DVM, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01750476
First received: December 10, 2012
Last updated: January 5, 2014
Last verified: January 2014
  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
Official Title: Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Resource links provided by NLM:


Further study details as provided by Ohio State University:

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 ]

Enrollment: 7
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750476

Locations
United States, Pennsylvania
UPMC Adolescent Clinic of Oakland
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Thomas Cherpes, DVM, MD
Investigators
Principal Investigator: Thomas L. Cherpes, MD assistant professor
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Cherpes, DVM, MD, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01750476     History of Changes
Other Study ID Numbers: PRO12010187, R01HD072663
Study First Received: December 10, 2012
Last Updated: January 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
oral contraception
Depo-Provera
Mirena

Additional relevant MeSH terms:
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014