Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total number of bleeding days
研究概览
简要总结
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.
详细描述
This study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. The subjects enrolling in the study will have documented heavy menstrual bleeding (HMB) and desire the levonorgestrel intrauterine system (LNG IUS) (Mirena®, Bayer, Inc. Pittsburgh, PA) for symptomatic relief. HMB for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. Subjects will be randomized to one of two groups. One group will receive norethindrone acetate for two consecutive months prior to LNG IUS insertion while the other group will proceed with direct insertion of the LNG IUS with no hormonal pre-treatment. Subjects will be followed for a period of 180 days post LNG IUS insertion. Bleeding patterns will be recorded daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •You must be between 18-45 years old
- •You have Heavy Periods
排除标准
- •You are pregnant
- •You are currently using hormonal contraception or hormonal therapy
- •You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)
- •You had an infected abortion within the last three months
- •You have abnormal or cancerous cells of the cervix or uterus
- •You have an actine infection in your genital organs
- •Known or suspected breast cancer
- •Active liver disease or tumors
- •Allergy to levonorgestrel or norethindrone
- •You currently have deep vein thrombosis, pulmonary embolism, or history of these conditions
- •you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions
研究组 & 干预措施
Norethindrone acetate pretreatment
This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
干预措施: Norethindrone acetate pretreatment (Drug)
No pretreatment
LVN IUS is placed without norethindrone acetate pretreatment.
干预措施: No pretreatment (Other)
结局指标
主要结局
Total number of bleeding days
时间窗: up to 180 days
Number of days on study calendars with menstrual flow
次要结局
- Menorrhagia Questionnaire(up to 180 days)