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Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

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ClinicalTrials.gov Identifier: NCT01750476
Recruitment Status : Terminated (PI and lab have re-located study to The Ohio State University)
First Posted : December 17, 2012
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Initiation of Oral Contraception (OC) Initiation of Depo-Provera (DMPA) Initiation of Mirena (LNG-IUD) Drug: Mirena Drug: Oral contraception Drug: Depo-Provera

Study Design

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
Study Start Date : December 2012
Primary Completion Date : April 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Women who choose to initiate Depo-Provera
Drug: Depo-Provera
Women who choose to initiate Mirena (intrauterine device)
Drug: Mirena
Oral contraception
Women who choose to initiate oral contraception
Drug: Oral contraception

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women interested in initiating hormonal contraceptive use

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750476

United States, Pennsylvania
UPMC Adolescent Clinic of Oakland
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Thomas Cherpes, DVM, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Thomas L. Cherpes, MD assistant professor
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Thomas Cherpes, DVM, MD, The Ohio State University:
oral contraception

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