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临床试验/NCT01731132
NCT01731132已完成不适用

DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.

Bayer0 个研究点目标入组 207 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
207
主要终点
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.

研究概览

简要总结

Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.

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 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-49 years old female.
  • Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
  • Women that has not used hormonal contraception in any form in the last 3 months.
  • Women who have no problems listening, reading or writing.
  • Women who gives their written consent to participate in the study.

排除标准

  • Women who have contraindications to use IUDs.
  • Women with previous experience with IUDs.
  • Women who initiates the use of IUDs for other purposes other than contraception.
  • Woman who is participating in a clinical trial at the time of initiating the study.

研究组 & 干预措施

Group 1

干预措施: Levonorgestrel IUD or Copper IUD (Drug)

结局指标

主要结局

Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.

时间窗: After 12 months

次要结局

  • Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.(Baseline)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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