MHRA grants Benilexa® One Handed (52mg levonorgestrel intrauterine system [IUS]) an 8-year licence for contraception in the UK

London, United Kingdom, Wednesday 18 September 2024 – Gedeon Richter UK Ltd. (“Gedeon Richter”) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has extended the licence for Benilexa One Handed from 6 to 8 years as a type of contraception.

While Benilexa One Handed is effective for 8 years as a contraceptive, it has demonstrated efficacy for 3 years in treating heavy menstrual bleeding. Therefore, Benilexa One Handed should be removed or exchanged after 8 years of use, or earlier if heavy or bothersome menstrual bleeding returns. 

“The extension of the Benilexa One Handed licence up to 8 years for contraception is welcome news,” said Dr Paula Briggs, Consultant in Sexual and Reproductive Health. “Prolonging the period between procedures may serve to reduce financial and capacity pressures on NHS sexual health services while limiting the burden for women.”

The 8-year UK licence is based on outcomes from two Phase 3 trials, one investigating the contraceptive protection of levonorgestrel IUS (“Access IUS study”) and the other evaluating women with heavy menstrual bleeding (“menstrual blood loss study”). Pivotal data from the Access IUS study showed the cumulative pregnancy rate calculated by the Pearl Index in women aged 16 to 35 years at trial entry using Benilexa One Handed (primary endpoint) was 0.15 (17,175 cycles, 95% CI: 0.02, 0.55) at the end of year 1 and 0.18 (78,229 cycles, 95% CI: 0.09, 0.33) at the end of year 8. There were 2 on-treatment pregnancies in year 7 (5,646 cycles) and 0 on-treatment pregnancies in year 8 (4,229 cycles), meaning that over 8 years and 78,229 cycles, 11 women fell pregnant on-treatment. In the menstrual blood loss study, pivotal data showed that Benilexa One Handed achieved a significant reduction in menstrual blood loss within 3 to 6 months of treatment. The volume of menstrual bleeding decreased by 88% in women with heavy menstrual bleeding by the end of 3 months of use and 82% reduction was sustained for the duration of the study (12 months). The effect was maintained during the extension phase of the study (up to 36 months).

The most common adverse events (occurring in ≥10% of users) for Benilexa One Handed are vaginal bacterial infections, vulvovaginal myocotic infections, acne, uterine/vaginal bleeding including spotting, oligomenorrhoea (infrequent menstrual periods), amenorrhoea (absence of menstrual periods), benign ovarian cysts and procedural pain and bleeding. Common adverse events (occurring in ≥1% to <10% of users) for Benilexa One Handed include depressive mood, nervousness, decreased libido, headache, migraine, presyncope, dizziness, abdominal pain/discomfort, nausea, abdominal distension, vomiting, back pain, pelvic pain, dysmenorrhoea (painful menstrual periods), vaginal discharge, vulvovaginitis, breast tenderness, breast pain, dyspareunia, uterine spasm, intrauterine contraceptive device expelled and increased weight.

An IUS is a type of long-acting reversible contraception (LARC) which releases progestogen and can prevent pregnancy for up to 8 years before needing to be replaced. The inserter is partially preloaded with the levonorgestrel IUS. The levonorgestrel IUS consists of a T-shaped polyethylene frame (T-frame) with a drug reservoir around the vertical stem. It is inserted into the womb by a doctor or nurse and can be removed at any time, with pregnancy possible once it is removed.

The preference for LARC has increased since 2018/2019, with 36% of women aged under 25 years and 53% of women aged over 25 years choosing a form of LARC (excluding injectables) as their main method of contraception at sexual and reproductive health services between 2022 and 2023. By contrast, the use of user-dependent methods has been on the decline over the last decade. The National Institute of Health and Care Excellence (NICE) recommend (Clinical Guideline CG30) women requiring contraception in the UK should be given information about and offered a choice of all methods, including LARC.

“Our mission is to support women whatever life might bring and we’re delighted another 8-year contraceptive option has been authorised for people in the UK,” said David Jordan, Medical Director UK and Ireland, Gedeon Richter. “With LARC becoming increasingly popular among women, the extended licence for Benilexa One Handed is a positive outcome for healthcare professionals and people who want choice when it comes to selecting their long-term birth control method or treatment for their heavy periods.”