The Prevalence and Predictors of Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean number of days with menstrual bleeding changes
研究概览
简要总结
The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.
详细描述
The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Included participants with normal regular menses prior to LNG-IUS
- •Included participants of any age, race, ethnicity, or parity
- •Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
- •Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days
排除标准
- •Heavy or prolonged menstrual bleeding (menorrhagia)
- •Actively breastfeeding
- •Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
- •Hormonal injectable contraceptive use within 6 months of enrollment
- •First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
- •Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern
结局指标
主要结局
Mean number of days with menstrual bleeding changes
时间窗: Six months after insertion of levonogestrel Intrauterine system
This include calculating the average number of days per month with bleeding-only, spotting-only,and bleeding and/or spotting in reproductive aged women using a 52 mg levonogestrel Intrauterine system (LNG-IUS) within the first six months ofuse, according to World Health Organization standards.
次要结局
未报告次要终点
研究者
Mariam Samy Lotfy
Resident doctor
Assiut University