Bayer Healthcare has launched Jaydess, an intrauterine system (IUS) that releases a constant level of levonorgestrel into the uterus, protecting against pregnancy for up to three years with an efficacy of more than 99%.
Now available in the UK, the new long-acting contraceptive (LNG IUS 13.5mg) measures only 28mm x 30mm x 1.55mm, with a narrow insertion tube providing women with an additional choice to find the right option for their individual needs.
The Jaydess device is placed in the uterus and gradually releases a very low-dose of levonorgestrel, so that very little of the hormone is released into the blood stream.
According to the company, the new product is targeted at women looking for a reliable, convenient long-term contraceptive option with a very low hormonal dose.
Unlike traditional contraceptive pills, Jaydess is highly effective with a Pearl Index of 0.33 at three years and this method of contraception does not demand women to think about their contraception every day, week or month.
However, awareness is low of alternative options and in particular, long-acting reversible methods, which are less dependent on user compliance such as intrauterine contraception (IUC).
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According to the company, around 30%-40% of pregnancies in the UK are unplanned and in England 40.6% of those end in termination.
NHS Hospital Trust Southport and Ormskirk locum consultant in sexual reproductive health Dr Paula Briggs said there is clearly an important role for healthcare professionals in ensuring they discuss all the contraceptive options available to women, to help them find the right option.
“Despite a number of benefits to using long-acting reversible contraception, utilisation of these methods is comparatively low,” Dr Briggs said.
“Intrauterine systems, like Jaydess, can help to give women contraceptive peace of mind, as once placed, they provide effective, reliable protection independent of user compliance.”
The approval was based on a Phase III multicentre, multi-national randomised open-label study conducted in 11 countries in Europe, Latin America, the US and Canada, with a trial involving 1,432 women aged 18-35, including both nulliparous and parous women.
The Pearl Index was the primary efficacy endpoint used to assess contraceptive reliability. The data showed that the new IUS is more than 99% effective in preventing pregnancy and was generally well-tolerated.
According to the company, Jaydess is not first choice for contraception in nulliparous women as clinical experience is limited.
The absolute rate of ectopic pregnancy observed in women using Jaydess is low since it has a high-contraceptive efficacy. This kind of complicated pregnancy may impact future fertility so benefits and risks of use needs to be carefully evaluated, particularly for nulliparous women.
Bayer HealthCare executive committee member and head of global development Dr Kemal Malik said: “We are pleased to provide women who are seeking contraception with a new and effective long-term option to consider with their healthcare providers.”