A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 16
- 主要终点
- Successful Insertions
研究概览
简要总结
The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.
详细描述
This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is a postmenarcheal and premenopausal woman of child bearing potential.
- •Subjects are at least 18 years of age, at the time of signing the informed consent.
- •Subject is overtly healthy as determined by medical evaluation.
排除标准
- •Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
- •History of previous IUD complications
- •Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
- •Known anatomical abnormalities of the cervix
- •Presence of acute pelvic inflammatory disease at the time of screening.
- •Postpartum endometritis.
- •Known or suspected uterine or cervical malignancy.
- •Uterine bleeding of unknown etiology.
- •Untreated acute cervicitis or vaginitis or other lower genital tract infection.
- •Conditions associated with increased susceptibility to pelvic infections.
- •Subjects with Wilson's disease.
结局指标
主要结局
Successful Insertions
时间窗: From enrollment to end of treatment at 3 months
The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt.
Overall Successful Insertions
时间窗: From enrollment to end of treatment at 3 months
The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt. A successful insertion includes participants with at least one successful insertion attempt with a maximum of two attempts.
次要结局
- Pelvic Infections(From enrollment to end of treatment at 3 months)
- IUS Expulsions and Dislocations(From enrollment to end of treatment at 3 months)
- Adverse Events related to Procedure(From enrollment to end of treatment at 3 months)
- Uterine Perforation and IUD Embedment(From enrollment to end of treatment at 3 months)
- Vasovagal Events(From enrollment to end of treatment at 3 months)
- Adverse Events(From enrollment to end of treatment at 3 months)
- Number of Participants With Pelvic Infections(From enrollment to end of treatment at 3 months)
- Number of Participants With Uterine Perforation and IUD Embedment(From enrollment to end of treatment at 3 months)
- Number of Participants With IUS Expulsions and Dislocations(From enrollment to end of treatment at 3 months)
- Number of Participants With Adverse Events(From enrollment to end of treatment at 3 months)
- Number of Participants With Adverse Events Related to Procedure(From enrollment to end of treatment at 3 months)
- Number of Participants With Vasovagal Events(From enrollment to end of treatment at 3 months)