Levosert® licence extended for contraception and heavy menstrual bleeding use

Gedeon Richter has announced that the licence for Levosert® (levonorgestrel intrauterine system (IUS)) has been extended to five years in its indications for contraception and the treatment of heavy menstrual bleeding.

The licence extension was based on new five-year data that studied the efficacy and safety of levonorgestrel IUS in 1,751 women aged 16-45 years old, and found that it is effective and well-tolerated over five years of use.

The licence extension means that levonorgestrel IUS will now offer an additional five-year treatment option to women seeking long-acting reversible contraception (LARC). This comes after a recent BBC report highlighted some of the issues surrounding sexual and reproduction health services and access to contraception.

An IUS is a type of LARC, which releases progestogen and can prevent pregnancy for three to five years. It is a T-shaped plastic device that is inserted into the womb by a doctor or nurse and can be removed at any time, with pregnancy possible as soon as it is removed.

LARC uptake in NHS sexual and reproductive health services nearly doubled between 2006/07 and 2016/17, with the number of women using LARC increasing to 39% versus 61% choosing user-dependent methods such as oral contraceptives.

The National Institute for Health and Care Excellence (NICE) currently recommends a levonorgestrel-releasing IUS as first-line treatment for women suffering from heavy menstrual bleeding with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or suspected or diagnosed adenomyosis.

Dr Paula Briggs, Consultant in Sexual and Reproductive Health, said: “The extended licence for levonorgestrel IUS to five years is great news for women as it will mean replacing their IUS less frequently than before.”

Dr Kriszta Zolnay, Managing Director of Gedeon Richter UK, said: “We are delighted. The licence extension to levonorgestrel IUS may allow women freedom to not worry about the risk of unplanned pregnancies for up to five years.”