Contraception, Mood Change
Conditions
Keywords
Intrauterine device (IUD), Depression, Stress hormones, Mood changes
Brief summary
Determine what kind of side effects women experience in the first year after they start using an intrauterine device.
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.
Interventions
DEVICEMirena
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.
DEVICEParaguard
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.
Sponsors
Society of Family Planning
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed