Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Mean change in hair cortisol concentration - 6 months
研究概览
简要总结
Determine what kind of side effects women experience in the first year after they start using an intrauterine device.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Age 18-39 years
- •Regular menstrual cycles
- •Getting an IUD for the purpose of contraception
排除标准
- •History of mood disorders
- •BMI less than 18.5 or greater than 35
- •Chronic medical conditions
- •Recently pregnant or lactating
结局指标
主要结局
Mean change in hair cortisol concentration - 6 months
时间窗: 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.
次要结局
- Mean change in hair cortisol concentration - 12 months(Baseline & 12 months post-insertion)
研究者
Nora Doty, MD
Instructor
Oregon Health and Science University