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临床试验/NCT01592058
NCT01592058已完成不适用

Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 427 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
427
试验地点
1
主要终点
Weight

研究概览

简要总结

The purpose of this study is to learn whether women who use progestin-only methods of birth control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared to women using the non-hormonal copper IUC (ParaGard).

The investigators primary hypothesis is that users of DMPA will gain excess weight and increase their BMI above the copper-IUC users; secondarily, the investigators will compare users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients enrolled in CHOICE between the ages of 18 and 45 who consented to future studies
  • Chose levonorgestrel-releasing IUD, copper IUD, the implant, or DMPA as their CHOICE baseline method
  • Has baseline height and weight data collected from the on-campus enrollment site
  • Able to come back to the on-campus enrollment site for consent process and enrollment activities

排除标准

  • Recent history of DMPA use before starting their baseline CHOICE method
  • Used current method for less than 11 months or more than 12 months and three weeks

结局指标

主要结局

Weight

时间窗: Baseline and 12 months

Change in weight from baseline at 12 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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