A Prospective, Randomized, Single Blind, Two Arms Controlled Study to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
The Primary Endpoints for comparison are based on the objective and subjective parameters.
The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years.
The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.
The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SCu300A IUB
干预措施: SCu300A IUB intrauterine device (Device)
T380A copper IUD
干预措施: T380A IUD (Device)
结局指标
主要结局
Pregnancy rate
时间窗: 24 months
Safety issues
时间窗: 24 months
Perforations, expulsions, mal-position etc
Patient experience
时间窗: 24 months
Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Discontinuation rate
时间窗: 24 months
次要结局
- Physician opinion(24 months)