Assessment of the Use of Two New Low-Dose Levonorgestrel-Releasing Intrauterine Systems as Contraceptives

Evaluation of: Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, Phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil. Steril. 97(3), 616–622.e3 (2012). A randomized, open-label, Phase II study was conducted in 37 centers in five European countries to assess the optimal dose for a new contraceptive levonorgestrel intrauterine system (LNG-IUS). Overall, 742 parous or nulliparous women aged 21–40 years were allocated to receive a LNG-IUS that initially releases 12 µg/day (LNG-IUS 12 ) or 16 µg/day (LNG-IUS 16 ) in vitro or the currently available device that releases 20 µg/day (LNG-IUS 20 ). The two new devices are shorter than the current one. Pearl Indices of 0.17, 0.82 and 0.00 for the LNG-IUS 12 , LNG-IUS 16 and LNG-IUS 20 , respectively, reflect the contraceptive efficacy of these devices. The mean number of bleeding and spotting days decreased in all three groups; however, this decrease was more significant in LNG-IUS 20 users. Placement of the new shorter devices was considered simple by providers, while patients reported significantly less pain with the two new devices compared with the current one. This study provided further insight into the development of two new LNG-IUS devices as contraceptives, with the additional possibility of using them to treat heavy menstrual bleeding or as endometrial protection during estrogen therapy.