The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant
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
- 否
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
Mohammed Khairy Ali
Assistant professor
Assiut University
