NCT02036203撤回不适用
A Prospective, Randomized, Single Blind, Two Arms Controlled Study of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Perforation rate
研究概览
简要总结
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.
Participants will be followed for one year and quality of life measurements will be measured during this period as well.
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
- 25 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •* Adult females aged 25-42
- •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%
- •Signed informed consent form
- •If took COCP at least had one cycle after use of OC
- •Exclusion Criteria(major)
- •Use IUB/IUD as an emergency contraception
- •A previously placed IUD that has not been removed
- •Pregnancy or suspicion of pregnancy
- •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 post abortal endometritis in the past 3 month
- •Mucopurulent cervicitis
- •Endometrial thickness more than 12 mm on insertion date
- •Known anemia
- •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
排除标准
- 未提供
研究组 & 干预措施
SCu300A IUB
Experimental
干预措施: SCu300A IUB (Device)
TCu380A
Active Comparator
干预措施: TCu380A IUD (Device)
结局指标
主要结局
Perforation rate
时间窗: During device insertion
Number of subjects with partial or complete perforation through the uterine wall
Device expulsion
时间窗: 12 months
Number of subjects with partially or fully ejected devices
Efficacy in preventing pregnancy
时间窗: 12 months
Number of women who become pregnant during the trial period.
Device malposition
时间窗: 12 months
Number of subjects with observed device malposition within the uterine cavity
次要结局
- Menorrhagia and dysmenorrhea rates(12 months)
研究者
研究点 (1)
Loading locations...
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