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Stress Hormones and IUDs

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT03499379
Collaborator
Society of Family Planning (Other)
39
Enrollment
1
Location
20.5
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine what kind of side effects women experience in the first year after they start using an intrauterine device.

Condition or Disease Intervention/Treatment Phase
  • Device: Mirena
  • Device: Paraguard

Detailed Description

The purpose of this study is to find out if there is a difference in levels of stress hormones in women who use copper or hormonal intrauterine devices (IUDs). This study will provide more information on the potential effect of levonorgestrel intrauterine system (LNG-IUS) use on an individual's stress response. Ultimately, this study hopes to provide data to better counsel women on potential mood effects of the LNG-IUS. From a research and clinical management perspective, hair cortisol may provide a tool to evaluate women at risk for discontinuation of hormonal contraception due to concern of mood symptoms.

Study Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
Actual Study Start Date :
Apr 16, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Women initiating use of an intrauterine device

Women obtaining a copper or hormonal intrauterine device for the purpose of contraception. A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex will be taken at the time of IUD insertion, 6 months post-insertion, and 12 months post-insertion.

Device: Mirena
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Other Names:
  • levonorgestrel intrauterine system

    • Device: Paraguard
    A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
    Other Names:
  • Copper T380A IUD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change in hair cortisol concentration - 6 months [Baseline & 6 months post-insertion]

      A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 6 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 6 months.

    Secondary Outcome Measures

    1. Mean change in hair cortisol concentration - 12 months [Baseline & 12 months post-insertion]

      A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 12 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 12 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Generally healthy

    • Age 18-39 years

    • Regular menstrual cycles

    • Getting an IUD for the purpose of contraception

    Exclusion Criteria:

    • History of mood disorders

    • BMI less than 18.5 or greater than 35

    • Chronic medical conditions

    • Recently pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • Society of Family Planning

    Investigators

    • Principal Investigator: Nora Doty, MD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nora Doty, MD, Instructor, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT03499379
    Other Study ID Numbers:
    • OHSU IRB 18244
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    Jan 7, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nora Doty, MD, Instructor, Oregon Health and Science University
    Intrauterine device (IUD)
    Depression
    Stress hormones
    Mood changes
    Additional relevant MeSH terms:
    Levonorgestrel

    Study Results

    No Results Posted as of Jan 7, 2020