Human Reproduction, Vol. 14, No. 4, 976-981,
April 1999
© 1999 European Society of Human Reproduction and Embryology
A multicentre efficacy and safety study of the single contraceptive implant Implanon ®
1 Chilean Institute of Reproductive Medicine, Santiago, Chile and the 2 Department of Obstetrics and Gynaecology, Semmelweis University, Budapest, Hungary and 3 Scientific Development Group, NV Organon, Oss, The Netherlands
An open, multicentre study was performed to assess efficacy, safety and acceptability of the single-rod contraceptive implant Implanon®. The study involved 635 young healthy women, who were sexually active and of childbearing potential. The women were followed up every 3 months over the entire study period. Originally the study was designed for 2 years, but was extended to 3 years in a group of 147 women from two centres. Altogether, 21 centres in nine different countries participated. The average age of the women was 29 years (range 18–42 years), of whom 83.5% had been pregnant in the past. No pregnancy occurred during treatment with Implanon®, resulting in a Pearl Index of 0 (95% confidence interval: 0.0–0.2). In the first 2 years, 31% had discontinued the treatment. Of the 147 women in the study extension, nine discontinued (6%) treatment. Bleeding irregularities was the main reason for discontinuation during the first 2 years of use (17.2%) and adverse experiences in the third year (3.4%). Implant insertion and removal were fast and uncomplicated in the vast majority (97%) of cases. Return of fertility was prompt. In conclusion, Implanon® has excellent contraceptive action during its lifetime of 3 years. The safety profile is acceptable and not essentially different from progestogens in general.
Key words: contraceptive implant/efficacy/Implanon®?/safety/vaginal bleeding
1 Study Group: Austria, Professor Dr J.Huber, I. UniversitaÐts Frauenklinik, Vienna; Belgium, Dr M.Vekemans/Dr A.Delvigne, HoÃpital Universitaire St Pierre, Brussels; Professor Dr J.Schwers, HoÃpital Erasme, Brussels; Chile, Dr H.B.Croxatto, Instituto Chileno de Medicina Reproductiva, Santiago; France, Professor P.Madelenat, Maternite HoÃpital Bichat, Paris; Dr D.Serfaty, HoÃpital Saint-Louis, Paris; Professor J.Colau, Centre Medico-Chirurgical Foch, Suresnes; Germany, Dr med E.Brandl/Dr med P.Tykal, General Practice, NoÐrdlingen; Dr med G.MaÐlzer, StaÐdt. Frauenklinik Leipzig; Dr med habil H.Stietzel, General Practice, Delitzsch; Professor Dr med T.Rabe, UniversitaÐts Frauenklinik Heidelberg; Dr med K.Hoffmann, General Practice, Karlsruhe; Dr D.Ullrich, Frauenklinik des Bezirkskrankenhauses, Dessau; Hungary, Professor L.KovaÂcs, Albert Szent-GyoÐrgyi Medical University, Szeged; Professor L.LampeÂ, University Medical School of Debrecen, Debrecen; Dr. J.Urbancsek, Semmelweis University, Budapest; Netherlands, Dr S.van der Linden, Ziekenhuis Eemland, Amersfoort; Dr T.Ypma, Scheperziekenhuis, Emmen; Dr R.Beerthuizen, Streekziekenhuis Koningin Beatrix, Winterswijk; Sweden, Dr I.OÐstlund, Regionsjukhuset, OÐrebro; UK, Professor J.R.Newton, Birmingham Maternity Hospital, Birmingham.
4 To whom correspondence should be addressed at: Clinical Development Department, NV Organon, PO Box 20, 5340 BH Oss, The Netherlands
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