NCT02167763已完成1 期
Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
Sebela Women's Health Inc.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Placement Feasibility
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the TCu380.
详细描述
This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety, Feasibility and Effectiveness of the VeraCept low-dose intrauterine copper contraceptive as compared to a concurrently controlled, commercially available standard copper "T" IUD (TCu380).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult females ages 18 to 42 (pre-menopausal)
- •Have had at least one child (parous) and currently seeking long acting reversible contraception
- •Normal uterine cavity as determined by ultrasound
- •Willing to sign informed consent
- •Able and willing to comply with study assessment schedule
排除标准
- •Post menopausal
- •Pregnant (at time of enrollment)
- •Known anatomical abnormalities of uterus, cervix and/or fallopian tubes
- •Diagnosed or in treatment for cancer
- •Untreated acute cervicitis
- •In treatment for active Pelvic Inflammatory Disease
- •Unexplained uterine bleeding or menometrorrhagia
- •Known allergy to copper (Wilson's Disease) or imaging contrast media
- •Unsuitable for study participation in the opinion of the Principal Investigator
结局指标
主要结局
Placement Feasibility
时间窗: At Enrollment
Ability of the clinician to successfully place the device
Contraceptive Effectiveness
时间窗: 12 Months
Number of subjects who become pregnant during the study period
次要结局
- Pain at Insertion(At Enrollment)
- Device Expulsion(12 Months)
- Tolerability(12 Months)
研究者
研究点 (1)
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