GyneFix-LNG: preliminary clinical experience with a copper and levonorgestrel-releasing intrauterine system.

Abstract

A novel intrauterine contraceptive drug delivery system derived from the conventional GyneFix intrauterine implant system is described and the preliminary results in 22 women are discussed. The first objective of the development of the GyneFix-levonorgestrel system was to reduce menstrual bleeding, whether or not related to the effect of copper, by combining a shortened version of the standard GyneFix implant, having a copper surface area of 200 mm2, with a system for the sustained intrauterine delivery of levonorgestrel. The results of this initial observational study indicate that the GyneFix-levonorgestrel system, apart from being well tolerated, is safe and effective. The levonorgestrel component appears to have a beneficial effect on the amount of bleeding. A study on menstrual blood loss will be carried out to substantiate this assumption.