ASRM 2016

CONTRACEPTION

Low-dose levonorgestrel-releasing IUD highly effective over 5 years The Skyla levonorgestrel-releasing intrauterine system has been found to be highly effective over 5 years.

K ristina Gemzell-Danielsson, MD, of the Karolin- ska Institutet, Stockholm, Sweden, explained that she and colleagues set out in this ran- domised, open-label, phase 3 study to assess the 5-year efficacy and safety of Skyla levonorg- estrel-releasing intrauterine system according to patients’ age, parity, and body mass index. “This was a development project to bring a new intrauterine system to market,” said Dr Gemzell-Dan- ielsson. “The goal of the International Committee for Contraceptive Research at the Population Council, of which I am a member, is to develop new safe and effective contraceptive methods to improve reproductive health. “One of the most effective methods born within the committee is Mirena, a 52-mg levonorgestrel- releasing intrauterine system. Yet a smaller device with an even lower hormonal content was needed.” Women aged 18–35 years with regular menstrual cycles (21–35 days) who requested contraception were recruited. The full analysis set included 1452 women (mean age 27.1 years; 39.5% nulliparous; mean body mass index 25.3 kg/m 2 ). The 5-year Pearl Index score was 0.29. Unadjusted 5-year Pearl Index scores were 0.18 (0.04–0.54) versus 0.36 (0.17–0.66) for women age 18–25 versus 26–35 years; 0.24 (0.07–0.63) ver- sus 0.32 (0.15–0.61) for nulliparous versus parous women, and 0.24 (0.11–0.64) versus 0.56 (0.13–1.42) for women with body mass index <30 vs ≥30 kg/m 2 . The 5-year Kaplan-Meier cumulative failure rate was 1.4%. This rate was 1.2% versus 1.6% in nulliparous versus parous women, 0.9% vs 1.8% in women aged 18–25 versus 26–35 years, and 1.3% versus 2.2% in women with body mass index <30 vs ≥30 kg/m 2 , respectively. Only 250 women had a body mass index ≥30 kg/m 2 , so conclusions on contraceptive efficacy according to body mass index could not be drawn. Risk of partial/complete expulsion was low regard- less of patient age, parity, or body mass index. Cumulative 5-year expulsion rates were 3.7% for both age groups, 1.8% versus 5.0% for nulliparous vs parous women, and 3.1% versus 6.9% in women with body mass index <30 versus ≥30 kg/m 2 . The cumulative 5-year ectopic pregnancy rate was 0.18 per 100 woman-years (0.14–0.28 across all

subgroups). Over 5 years, 328 (22.6%) women dis- continued due to any adverse event. This rate was 24.2% versus 21.5% in nulliparous versus parous women. Overall, the most frequent adverse events that led to discontinuation were vaginal haemor- rhage (3.5%), system expulsion (3.0%) and pelvic pain (3.0%). Dr Gemzell-Danielsson concluded that the Skyla levonorgestrel-releasing intrauterine system was highly effective over 5 years, regardless of age or parity. The system was associated with low rates of expulsion and ectopic pregnancy. Overlapping 95% confidence intervals for all groups suggested no major differences between them. Skyla offers women a lower-dose 5-year contraceptive option. Dr Gemzell-Danielsson said, “We have shown that a smaller intrauterine system results in less pain at placement. Pain at insertion is one of the major bar- riers to increased use of intrauterine contraception. Many women prefer non- or low-dose hormonal methods and local methods.” She added, “Intrauterine contraception with a lev- onorgestrel-releasing device is one of the most effective contraceptive methods available. It is safe, reduces bleeding, and confers several positive health benefits. This smaller, lower-dose device, combined several positive features, is easier to insert than larger devices, and is effective for the same 5-year duration. Intrauterine contraception, with the highest user satisfaction, is cost-effective and exerts low environmental impact.” “The World Health Organisation, International Fed- eration of Gynecology and Obstetrics, and other agencies recognise that increased use of intrau- terine contraception (belonging to the long-acting, reversible contraceptive class) will result in reduced maternal mortality and morbidity. This class, with its safety, high efficacy, and high user satisfaction, will reduce unplanned, unwanted pregnancy and unsafe abortions.” Finally, she said, “The goal of these agencies is to broaden the use of intrauterine systems in general, and specifically, to a younger age group. Intrau- terine contraception is underutilised, and many young women suffer from anaemia and low iron levels. Intrauterine systems exert a positive impact by reducing bleeding and improving haemoglobin levels.”

KRISTINA GEMZELL-DANIELSSON

" Intrauterine

contraception is underutilised, and many young women suffer from anaemia and low iron levels. Intrauterine systems exert

a positive impact by reducing bleeding and improving haemoglobin levels.

Elsevier Conference Series • ASRM 2016 14