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临床试验/NCT01590563
NCT01590563已完成不适用

A Study to Evaluate the Safety and Initial Efficacy of a Spherical Copper Intrauterine Contraceptive Device the IUB(tm)

Ocon Medical Ltd.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Rates of Uterine Perforation

研究概览

简要总结

Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Apart for an anticipated reduction in the rate of stated complications, its smaller size and mallable characteristics are also expected to improve user experience. The clinical trial is intended to evaluate the safety and initial efficacy of this novel device.

详细描述

A copper IUD (intrauterine device or coil) is a type of intrauterine contraceptive device. Most IUDs have a plastic T-shaped frame which is wrapped in copper wire and sleeves. The device has to be fitted inside and removed from the uterine cavity by a doctor or qualified medical practitioner. It remains in place the entire time pregnancy is not desired.

The IUD is a long acting reversible contraceptive, with different IUDs intended to last for different lengths of time, usually between 3 and 10 years. The length of time that the device lasts depends mainly on the amount of exposed copper, which is indicated, in square millimeters, by a number in the name of each device (i.e., the Paragard T-380A has 380 square millimeters of exposed copper).

The IUD is the world's most widely used method of reversible birth control, currently used by over 175 million women.

The mechanism of IUDs is not well understood. It is known however that the presence of a device in the uterus prompts the release of leukocytes and prostaglandins by the endometrium. These substances are hostile to both sperm and eggs; the presence of copper increases the spermicidal effect. The general medical consensus is that spermicidal and ovicidal mechanisms are the only way in which IUDs work. Some physicians and medical texts have suggested they may have a secondary effect of interfering with the development of pre-implanted embryos; this secondary effect is considered more plausible when the IUD is used as emergency contraception.

Second-generation copper-T IUDs have failure rates of less than 1% per year, and cumulative 10-year failure rates of 2-6%. A copper IUD may also be used as emergency contraception. If an IUD is inserted within five days of unprotected intercourse, a woman's chance of pregnancy is reduced to that of ongoing IUD users.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female aged 25-42
  • Free willing to fully comply with treatment process
  • Healthy women
  • Married or in a steady relationship. Blood hemoglobin >11.5gr%
  • Signed informed consent form

排除标准

  • Pregnancy or suspicion of pregnancy
  • Use of other contraception methods
  • Abnormalities of the uterus resulting in distortion of the uterine cavity
  • Acute current or past history of pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
  • Postpartum endometritis or postabortal endometritis in the past 3 months
  • Known or suspected uterine or cervical malignancy
  • Genital bleeding of unknown etiology
  • Mucopurulent cervicitis
  • Wilson's disease
  • Allergy to any component of IUB™
  • A previously placed IUD that has not been removed
  • Known intolerance or allergy to copper and/or copper IUDs
  • Medication that may interfere with the subject's ability to complete the protocol
  • 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
  • Planned pregnancy during the follow-up period
  • Participation in another clinical trial
  • Anemia of any kind or blood hemoglobin lower than 11.5gr%.

结局指标

主要结局

Rates of Uterine Perforation

时间窗: During installation

Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.

Efficacy in Preventing Pregnancy

时间窗: 12 months

Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.

次要结局

  • Occurrence of Malposition, Expulsion.(12 months)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dana Raveh Arbel

VP Clinical

Ocon Medical Ltd.

研究点 (2)

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