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临床试验/NCT05040282
NCT05040282已完成不适用

The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant

Assiut University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Number of women with amenorrhea after using etonogestrel subdermal implant

研究概览

简要总结

The etonogestrel subdermal implant has been available worldwide for more than 15 years. The action of etonogestrel subdermal implant is principal via suppression of ovulation, but it also has effects on cervical mucus and in some women induces suppression of endometrial proliferation. Several studies have confirmed its high efficacy and convenience. The uterine bleeding problems and in particular irregular bleeding and amenorrhea are major side effects of etonogestrel subdermal implant. A considerable number of patients request early removal due to bleeding changes. Amenorrhea occurs in about 22% in etonogestrel subdermal implant users. Despite the presence of many studies that reported the prevalence of etonogestrel subdermal implant-associated bleeding, little is known about the predictive factors affecting menstrual bleeding patterns especially amenorrhea after etonogestrel subdermal implant insertion. These predictive factors should be provided prior to the etonogestrel subdermal implant insertion which may improve acceptance and continuation of etonogestrel subdermal implant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 18 and 40 years.
  • Women who are not lactating.
  • Non-pregnant women
  • Women have regular menstrual cycles every 21-35 days with a typical cycle length variation of no more than 5 days.
  • Women who will ESI only for pregnancy prevention for at least 12 months.
  • Have not any medical or gynecologic problems.

排除标准

  • Women with any contraindications for progesterone-only contraception in accordance with WHO eligibility criteria.
  • Refuse participation in the study.

结局指标

主要结局

Number of women with amenorrhea after using etonogestrel subdermal implant

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Assistant professor

Assiut University

研究点 (2)

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