A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device
Condition: Contraception
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      IUDs do not protect against STDs or PID.

      Made from a shape memory alloy of a specific size and shape, the SCu300A IUB™ is inserted
      through an insertion tube much like regular IUDs, however, when pushed out, in the uterus, it
      takes a spherical shape. An important feature includes its downwards curving opposite to the
      uterine fundus as it emerges out of the tube, minimizing the risk of perforation. The three
      dimensional shape's elasticity allows for better amenability to the uterus, nullifying the
      possibility of malposition and its final outer diameter reducing the probability of
      expulsion. Lacking rigid or protruding segments and being significantly smaller than other
      IUDs, the IUB™ is expected to reduce distortion and tissue irritation, possibly resulting in
      less bleeding, discomfort and pain, leading to lower discontinuation rates. A thread is
      attached to the IUB™ to allow easy removal.

      The trialed IUB™ will be copper-based (Cu surface area of 300mm2).

      This study aims to assess the IUB™'s safety and initial efficacy. Endpoints include the
      assessment of changes in discomfort, pain and menorrhea, changes in the endometrium
      discontinuation rates as well as user experience. These results will be used as regulatory
      evidence and will also help in reaffirming the assumption that the IUB™'s design contributes
      to lower complication and side effect rates.
    

Intervention name(s): IUD
Intervention type(s): Device
Intervention description(s): Insertion of a spherical IUD, one year follow-up
Other intervention name(s): SCu300A IUB(tm)
Intervention model: Single Group Assignment
Intervention model description: Intrauterine device
Masking: None (Open Label)
Primary purpose: Prevention