NCT01216358已完成不适用
The Boston Migraine and Contraception Study
Planned Parenthood League of Massachusetts1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2010年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Proportion of days with headache
研究概览
简要总结
The objectives of this prospective, descriptive study are to:
- generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and
- identify predictive factors for clinically significant changes in headache attributable to HC use.
The investigators hypothesize that:
- Most women with pre-existing migraine will have no significant change from baseline headache frequency or clinical impact attributable to HC at 3 months following initiation; a minority will report clinically significant worsening or improvement
- The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users
- There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Proficiency in English
- •Medically eligible for her chosen form of contraception per standard PPLM clinic protocol
- •(For Study Arm A) Desire initiation of an estrogen/progesterone contraceptive method at time of clinic presentation and evaluation
- •(For Study Arm B) Desire initiation of a progesterone only contraceptive method at time of clinic presentation and evaluation
- •(For Control Arm) Initiating a non-hormonal contraceptive, or not initiating any contraceptive method
- •(For Control Arm) Stated intention of not initiating any hormonal contraception over the 3 month study period
- •Agreeing to study procedures
排除标准
- •Inability to speak and read English
- •(For Control Arm) Use of hormonal contraceptive in the past 3 months
- •(For Control Arm) Been pregnant in the past 3 months
- •States an intention to discontinue use of their newly initiated contraceptive (or lack of contraceptive) before the end of the 3 month study period
- •Unwilling or unable to comply with study follow-up procedures
- •Inability to give informed consent
- •Previous participation in this study
结局指标
主要结局
Proportion of days with headache
时间窗: 84 days
Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency
次要结局
- Averages for percentage of headache days/28 days(84 days)
研究者
研究点 (1)
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