Stress Hormones and IUDs

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

Detailed Description
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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.

Official Title
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Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration

Conditions
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Contraception, Mood Change

Intervention / Treatment
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* Device: Mirena
* Device: Paraguard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women initiating use of an intrauterine device<br>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<br>* 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.<br>* Other names: levonorgestrel intrauterine system;Device: Paraguard<br>* 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.<br>* Other names: Copper T380A IUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline & 6 months post-insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline & 12 months post-insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine device (IUD), Depression, Stress hormones, Mood changes