Stress Hormones and IUDs

Oregon Health and Science University39 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Contraception Mood Change

Interventions

MirenaDEVICE

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.

ParaguardDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Mean change in hair cortisol concentration - 6 months

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.

Time frame: Baseline & 6 months post-insertion

Secondary Outcomes

Mean change in hair cortisol concentration - 12 months

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.

Time frame: Baseline & 12 months post-insertion

Data from ClinicalTrials.gov

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