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
- Patient experience
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
- •Adult females aged 18-45
- •Free and willing to fully comply with treatment process
- •Healthy women seeking LARC
- •Married or in a steady relationship (at least 1 year)
- •Blood hemoglobin >11.5gr/dL
- •Signed informed consent form
- •If took COCP at least had one cycle after use of OC
排除标准
- •Use IUB/IUD as an emergency contraception
- •A previously placed IUD that has not been removed
- •Pregnancy or suspicion of pregnancy
- •Immediately post-abortion or post-partum - unless had at least one free cycle
- •Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
- •History of pelvic inflammatory disease, recent or remote.
- •Postpartum endometritis or postabortal endometritis in the past 3 month
- •Mucupurulent cervicitis
- •Endometrial thickness more than 12 mm on insertion date
- •Known anemia (except thalassemia, sickle cell, chronic anemia)
- •Severe Mennorrhagia or severe Dysmenorrhea
- •History of previous IUD complications
- •Dysfunctional uterine bleeding
- •Undiagnosed uterine bleeding
- •Malignancy or suspected malignant disease of female inner or outer genitalia
- •Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities
- •Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.
- •Medication that may interfere with the subject's ability to complete the protocol
- •Use of injectable contraception in the previous year
- •Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
- •A history of alcohol or drug abuse
- •Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- •Pregnancy or pregnancy planned during the year
- •Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study
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
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
Pregnancy rate
时间窗: 24 months
Safety issues
时间窗: 24 months
Perforations, expulsions, mal-position etc
次要结局
- Physician opinion(24 months)