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What is an IUD?

The intrauterine device (IUD) is a small plastic T-shaped device that holds a long-acting contraceptive drug in place. It is inserted into the uterus by a healthcare professional. An IUD's contraceptive action begins as soon as the device is placed in the uterus and stops as soon as it is removed, making it a reversible form of contraception.

There are two types of IUD available in the United States.

• Copper-Releasing: This type of IUD can remain in the uterus for up to 10 years and does not release any hormones. Instead, copper ions are slowly released and are responsible for the contraceptive activity. This type of IUD is associated with increased menstrual bleeding in some women.
  
  
• Progestin-Releasing: This type of IUD can remain in the uterus for up to 5 years. Also known as a levonorgestrel-releasing intrauterine system, or LNG-IUS, it releases a small amount of progestin, a hormone. Progestin is not the same as estrogen, and since it is released in low doses, the level of hormones in the body with an LNG-IUS is much lower than with oral or implantable contraception. LNG-IUS is also effective in preventing heavy bleeding. Medicines360 is developing a new device of this type, which is known as LNG20.
  
  

What is the difference between Menorrhagia and Contraception?
Menorrhagia is a term for excessive or prolonged menstrual bleeding that occurs at regular intervals. LNG-IUS devices have proven effective at treating this condition, and Uteron is currently conducting a pivotal clinical trial in Europe for Menorrhagia with our LNG20 IUS.

In the United States, Medicines360 is conducting a Phase III clinical trial to evaluate our LNG20 IUS product for long-term, reversible contraception, or the prevention of pregnancy.

Why are there separate approvals for the US and Europe?
In the US, the Food and Drug Administration must review and approve all drugs and devices to ensure they are safe and effective. If so, they may be marketed to consumers and healthcare professionals in the US.

European countries have their own regulatory agency which reviews and approves drugs and devices. The process is separate, but similar to that of the FDA, and once approval is granted products may be marketed in European countries.

What is Medicines360’s role?
Medicines360 is responsible for the clinical trial design and regulatory strategy, and a Phase III clinical trial in the US to test the LNG-IUS product for safety and effectiveness in preventing pregnancy. Once approval is granted, we will bring the product to market with the goal of providing access to this treatment to as many women as possible, regardless of income or insurance status.

How do I enroll in the trial?
The US clinical trial for contraception is currently enrolling. For more information, please see our listing at www.clinicaltrials.gov (enter “medicines360” in the search window) or contact the study director at clinicaltrials@medicines360.org.