NCT01750476

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

December 10, 2012

Last Update Submit

January 5, 2014

Conditions

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

Keywords

oral contraceptionDepo-ProveraMirena

Outcome Measures

Primary Outcomes (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

    Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive

Study Arms (3)

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

Interventions

MirenaDRUG
Mirena
Oral contraceptionDRUG
Oral contraception
Depo-ProveraDRUG
Depo-Provera

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Women interested in initiating hormonal contraceptive use

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Adolescent Clinic of Oakland

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Vicetti Miguel RD, Hendricks RL, Aguirre AJ, Melan MA, Harvey SA, Terry-Allison T, St Leger AJ, Thomson AW, Cherpes TL. Dendritic cell activation and memory cell development are impaired among mice administered medroxyprogesterone acetate prior to mucosal herpes simplex virus type 1 infection. J Immunol. 2012 Oct 1;189(7):3449-61. doi: 10.4049/jimmunol.1103054. Epub 2012 Aug 31.

    PMID: 22942424BACKGROUND

  • Vicetti Miguel RD, Maryak SA, Cherpes TL. Brefeldin A, but not monensin, enables flow cytometric detection of interleukin-4 within peripheral T cells responding to ex vivo stimulation with Chlamydia trachomatis. J Immunol Methods. 2012 Oct 31;384(1-2):191-5. doi: 10.1016/j.jim.2012.07.018. Epub 2012 Jul 29.

    PMID: 22850275BACKGROUND

MeSH Terms

Interventions

LevonorgestrelContraceptives, OralMedroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanes

Study Officials

  • Thomas L. Cherpes, MD

    assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 17, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)