A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of menstrual bleeding days
研究概览
简要总结
The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age.
Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea.
In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs.
The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users.
This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female subject.
- •Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
- •History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.
排除标准
- •Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
- •Contraindications to use 13,5 LNG-IUD.
- •Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
- •Known bleeding irregularities.
- •Pregnancy or breast-feeding.
研究组 & 干预措施
Levonorgestrel IUD
13,5 mg Levonorgestrel intrauterine device
干预措施: Levonorgestrel (13,5 mg) intrauterine device (Drug)
Copper IUD
Copper (380mm2) intrauterine device
干预措施: Cooper (380mm2) intrauterine device (Device)
结局指标
主要结局
Number of menstrual bleeding days
时间窗: 90 days
Daily recorded during 90 days treatment period
Amount of Menstrual bleeding
时间窗: 90 days
Classified using a 5-item Likert-like scale from none to heavy, a pictorial blood loss assessment chart (PBAC), and ferritin and haemoglobin blood test determinations
次要结局
未报告次要终点