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OpenTrials
Completed

NCT Number: NCT03499379

Stress Hormones and IUDs

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

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Key information

Conditions

Contraception Behavior Behavioral Symptoms Depression Mood Change

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirena

Device

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

Paraguard

Device

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

Primary outcomes

  1. Mean change in hair cortisol concentration - 6 months

    Time frame: 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 outcomes

  1. Mean change in hair cortisol concentration - 12 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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