STUDY QUESTION Does intensive counselling before insertion and throughout the first year of use have any influence on discontinuation rates due to unpredictable menstrual bleeding in users of three long-Acting reversible contraceptives (LARCs)? SUMMARY ANSWER Intensive counselling had a similar effect to routine counselling in terms of discontinuation rates due to unpredictable menstrual bleeding in new users of the contraceptives. WHAT IS KNOWN ALREADY Contraceptive efficacy and satisfaction rates are very high with LARCs, including the etonogestrel (ENG)-releasing implant, the levonorgestrel-releasing intrauterine system (LNG-IUS) and the TCu380A intrauterine device (IUD). However, unpredictable menstrual bleeding constitutes the principal reason for premature discontinuation, particularly in the cases of the ENG-implant and the LNG-IUS. STUDY DESIGN, SIZE, DURATION A randomized clinical trial was conducted between 2011 and 2013, and involved 297 women: 98 ENG-implant users, 99 LNG-IUS users and 100 TCu380A IUD users. PARTICIPANTS, SETTING, METHODS Women accepting each contraceptive method were randomized into two groups after the women chose their contraceptive method. Group I received routine counselling at the clinic, including information on safety, efficacy and side effects, as well as what to expect regarding bleeding disturbances. Group II received 'intensive counselling'. In addition to the information provided to those in Group I, these women also received leaflets on their chosen method and were seen by the same three professionals, the most experienced at the clinic, throughout the year of follow-up. These three professionals went over all the information provided at each consultation. Women in both groups were instructed to return to the clinic after 45 (±7) days and at 6 and 12 (±1) months after insertion. They were instructed to record all bleeding episodes on a menstrual calendar specifically provided for this purpose. Additionally, satisfaction with the method was evaluated by a questionnaire completed by the women after 12 months of use of the contraceptive method. MAIN RESULTS AND THE ROLE OF CHANCE There were no significant differences between the intensive and routine counselling groups on the discontinuation rates due to unpredictable menstrual bleeding of the three contraceptives under evaluation. The 1-year cumulative discontinuation rates due to menstrual bleeding irregularities were 2.1, 2.7 and 4.0% and the continuation rates were 82.6, 81.0 and 73.2%, for the ENG-implant, the LNG-IUS or the TCu380A IUD users, respectively. The main reasons for discontinuation of the methods were weight gain in users of the ENG-implant and expulsion of the TCu380A. LIMITATIONS, REASONS FOR CAUTION The main limitations are that we cannot assure generalization of the results to another settings and that the routine counselling provided by our counsellors may already be appropriate for the women attending the clinic and so consequently intensive counselling including written leaflets was unable to influence the premature discontinuation rate due to unpredictable menstrual bleeding. Additionally, counselling could discourage some women from using the LARC methods offered in the study and consequently those women may have decided on other contraceptives. WIDER IMPLICATIONS OF THE FINDINGS Routine counselling may be sufficient for many women to help reduce premature discontinuation rates and improve continuation rates and user satisfaction among new users of LARC methods. TRIAL REGISTRATION NUMBER The trial was registered at clinicaltrials.gov (NCT01392157). STUDY FUNDING/COMPETING INTEREST(S) The study was partially funded by the Fundação de Apoio a Pesquisa do Estado de São Paulo (FAPESP) grant # 2012/01379-0, the Brazilian National Research Council (CNPq) grant #573747/2008-3 and by Merck (MSD), Brazil under an unrestricted grant. The LNG-IUS were donated by the International Contraceptive Access Foundation (ICA) and the copper IUD by Injeflex, São Paulo, Brazil. L.B. has occasionally served on the Board of MSD, Bayer and Vifor. © 2014 The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.29713931399Agrawal, A., Robinson, C., An assessment of the first 3 years use of Implanon in Luton (2005) J Fam Plann Reprod Health Care, 31, pp. 310-312Andersson, K., Odlind, V., Rybo, G., Levonorgestrel-releasing and copperreleasing (Nova T) IUDs during five years of use: A randomized comparative trial (1994) Contraception, 49, pp. 56-72Backman, T., Huhtala, S., Luoto, R., Tuominen, J., Rauramo, I., Koskenvuo, M., Advance information improves user satisfaction with the levonorgestrel intrauterine system (2002) Obstet Gynecol, 99, pp. 608-613Bahamondes, M.V., De Lima, Y., Teich, V., Bahamondes, L., Monteiro, I., Resources and procedures in the treatment of heavy menstrual bleeding with the levonorgestrel-releasing intrauterine system (LNG-IUS) or hysterectomy in Brazil (2012) Contraception, 86, pp. 244-250Baldaszti, E., Wimmer-Puchinger, B., Löschke, K., Acceptability of the long-term contraceptive levonorgestrel-releasing intrauterine system (Mirena): A 3-year follow-up study (2003) Contraception, 67, pp. 87-91Bitzer, J., Cupanik, V., Fait, T., Gemzell-Danielsson, K., Grob, P., Oddens, B.J., Pawelczyk, L., Unzeitig, V., Factors influencing womens selection of combined hormonal contraceptive methods after counselling in 11 countries: Results from a subanalysis of the CHOICE study (2013) Eur J Contracept Reprod Health Care, 18, pp. 372-380Croxatto, H.B., Clinical profile of Implanon: A single-rod etonogestrel contraceptive implant (2000) Eur J Contracept Reprod Health Care, 5, pp. 21-28Croxatto, H.B., Mechanisms that explain the contraceptive action of progestin implants for women (2002) Contraception, 65, pp. 21-27Croxatto, H.B., Urbancsek, J., Massai, R., Coelingh Bennink, H., Van Beek, A., A multicentre efficacy and safety study of the single contraceptive implant Implanon (1999) Implanon Study Group. Hum Reprod, 14, pp. 976-981Davie, J.E., Walling, M.R., Mansour, D.J., Bromham, D., Kishen, M., Fowler, P., Impact of patient counseling on acceptance of the levonorgestrel implant contraceptive in the United Kingdom (1996) Clin Ther, 18, pp. 150-159Diaz, J., Bahamondes, L., Monteiro, I., Petta, C., Hildalgo, M.M., Arce, X.E., Acceptability and performance of the levonorgestrel-releasing intrauterine system (Mirena) in Campinas (2000) Brazil. Contraception, 62, pp. 59-61Ferreira, J.M., Nunes, F.R., Modesto, W., Gonçalves, M.P., Bahamondes, L., Reasons for Brazilian women to switch from different contraceptives to long-Acting reversible contraceptives (2014) Contraception, 89, pp. 17-21Gemzell-Danielsson, K., Thunell, L., Lindeberg, M., Tydén, T., Marintcheva-Petrova, M., Oddens, B.J., Comprehensive counseling about combined hormonal contraceptives changes the choice of contraceptive methods: Results of the CHOICE program in Sweden (2011) Acta Obstet Gynecol Scand, 90, pp. 869-877Harvey, C., Seib, C., Lucke, J., Continuation rates and reasons for removal among Implanon users accessing two family planning clinics in Queensland (2009) Australia. Contraception, 80, pp. 527-532Hidalgo, M., Bahamondes, L., Perrotti, M., Diaz, J., Dantas-Monteiro, C., Petta, C., Bleeding patterns and clinical performance of the levonorgestrel- releasing intrauterine system (Mirena) up to two years (2002) Contraception, 65, pp. 129-132Kalmuss, D., Davidson, A.R., Cushman, L.F., Heartwell, S., Rulin, M., Determinants of early implant discontinuation among low-income women (1996) Fam Plann Perspect, 28, pp. 256-260Lakha, F., Glasier, A.F., Continuation rates of Implanon in the UK: Data from an observational study in a clinical setting (2006) Contraception, 74, pp. 287-289Mansour, D., Bahamondes, L., Critchley, H., Darney, P., Fraser, I.S., The management of unacceptable bleeding patterns in etonogestrel- releasing contraceptive implant users (2011) Contraception, 83, pp. 202-210Peipert, J.F., Zhao, Q., Allsworth, J.E., Petrosky, E., Madden, T., Eisenberg, D., Secura, G., Continuation and satisfaction of reversible contraception (2011) Obstet Gynecol, 117, pp. 1105-1113Peterson, H.B., Curtis, K.M., Clinical practice. Long-Acting methods of contraception (2005) N Engl J Med, 353, pp. 2169-2175Rubenstein, J., Rubenstein, P., Barter, J., Pittrof, R., Counselling styles and their effect on subdermal contraceptive implant continuation rates (2011) Eur J Contracept Reprod Health Care, 16, pp. 225-228Sheng, J., Zhang, W.Y., Zhang, J.P., Lu, D., The LNG-IUS study on adenomyosis: A 3-year follow-up study on the efficacy and side effects of the use of levonorgestrel intrauterine system for the treatment of dysmenorrhea associated with adenomyosis (2009) Contraception, 79, pp. 189-193Smith, A., Reuter, S., An assessment of the use of Implanon in three community services (2002) J Fam Plann Reprod Health Care, 28, pp. 193-196Suhonen, S., Haukkamaa, M., Jakobsson, T., Rauramo, I., Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: A comparative study (2004) Contraception, 69, pp. 407-412Winner, B., Peipert, J.F., Zhao, Q., Buckel, C., Madden, T., Allsworth, J.E., Secura, G.M., Effectiveness of long-Acting reversible contraception (2012) N Engl J Med, 366, pp. 1998-2007Wong, R.C., Bell, R.J., Thunuguntla, K., McNamee, K., Vollenhoven, B., Implanon users are less likely to be satisfied with their contraception after 6 months than IUD users (2009) Contraception, 80, pp. 452-456A multicentred Phase III comparative study of two hormonal contraceptive preparations given once-A-month by intramuscular injection II the comparison of bleeding patterns (1989) Contraception, 40, pp. 531-551. , World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction, Task Force on Long-Acting Systemic Agents for Fertility Regulation