Levonorgestrel-releasing intrauterine system (LNG-IUS 12) for prevention of pregnancy for up to five years

References

• Say L, Chou D, Gemmill A, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323–33. ​
   PubMed Web of Science ®Google Scholar
• WHO Maternal Mortality FACT Sheet Nov. 2016 Available at: http://www.who.int/mediacentre/factsheets/fs348/en/. ​
   Google Scholar
• Ahmed S, Li Q, Liu L, et al. Maternal deaths averted by contraceptive use: an analysis of 172 countries. Lancet. 2012;380(9837):111–125.
   PubMed Web of Science ®Google Scholar
• Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843–852.
   PubMed Web of Science ®Google Scholar
• Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible contraceptive methods among U.S. women, 2009-2012. Obstet Gynecol. 2015;126(5):917–927.
   PubMed Web of Science ®Google Scholar
• Trussell J, Guthrie KA. Contraceptive Technology. 20th Edition. Ardent Media, Inc; New York, NY:50. 2010. ​
   Google Scholar
• United Nations, Trends in contraceptive use worldwide 2015. [cited 2017 Jun 14]. Available at: http://www.un.org/en/development/desa/population/publications/pdf/family/trendsContraceptiveUse2015Report.pdf. ​
   Google Scholar
• Milsom I, Andersson K, Jonasson K, et al. The influence of the Gyne-T 380S IUD on menstrual blood loss and iron status. Contraception. 1995;52(3):175–179.
   PubMed Web of Science ®Google Scholar
• Hubacher D, Chen PL, Park S. Side effects from the copper IUD: do they decrease over time? Contraception. 2009;79(5):356–362.
   PubMed Web of Science ®Google Scholar
• Godfrey EM, Folger SG, Jeng G, et al. Treatment of bleeding irregularities in women with copper-containing IUDs: a systematic review. Contraception. 2013;87(5):549–566.
   PubMed Web of Science ®Google Scholar
• Luukkainen T, Toivonen J. Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception. 1995;52(5):269–276.
   PubMed Web of Science ®Google Scholar
• Mejia M, McNicholas C, Madden T, et al. Association of baseline bleeding pattern on amenorrhea with levonorgestrel intrauterine system use. Contraception. 2016;94(5):556–560.
   PubMed Web of Science ®Google Scholar
• Hidalgo M, Bahamondes L, Perrotti M, et al. Bleeding patterns and clinical performance of the levonorgestrel-releasing intrauterine system (Mirena) up to two years. Contraception. 2002;65(2):129–132.
   PubMed Web of Science ®Google Scholar
• Lethaby A, Hussain M, Rishworth JR, et al. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015;4:CD002126.pub3. ​
   Web of Science ®Google Scholar
• Heinemann K, Reed S, Moehner S, et al. Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European active surveillance study for intrauterine devices. Contraception. 2015;91(4):280–283.
   PubMed Web of Science ®Google Scholar
• Edelman A, Lew R, Cwiak C, et al. Acceptability of contraceptive-induced amenorrhea in a racially diverse group of US women. Contraception. 2007;75(6):450–453.
   PubMed Web of Science ®Google Scholar
• Den Tonkelaar I, Oddens BJ. Preferred frequency and characteristics of menstrual bleeding in relation to reproductive status, oral contraceptive use, and hormone replacement therapy use. Contraception. 1999;59(6):357–362.
   PubMed Web of Science ®Google Scholar
• d’Arcangues C, Jackson E, Brache V, et al. Study group on progestogen-induced vaginal bleeding disturbances. Women’s views and experiences of their vaginal bleeding patterns: an international perspective from Norplant users. Eur J Contracept Reprod Health Care. 2011;16(1):9–17.
   PubMed Web of Science ®Google Scholar
• Glasier AF, Smith KB, Van Der Spuy ZM, et al. Amenorrhea associated with contraception-an international study on acceptability. Contraception. 2003;67(1):1–8.
   PubMed Web of Science ®Google Scholar
• Merki-Feld GS, Breitschmid N, Seifert B, et al. A survey on Swiss women’s preferred menstrual/withdrawal bleeding pattern over different phases of reproductive life and with use of hormonal contraception. Eur J Contracept Reprod Health Care. 2014;19(4):266–275.
   PubMed Web of Science ®Google Scholar
• Newton VL, Hoggart L. Hormonal contraception and regulation of menstruation: a study of young women’s attitudes towards ‘having a period’. J Fam Plann Reprod Health Care. 2015;41(3):210–215.
   PubMed Web of Science ®Google Scholar
• Clark LR, Barnes-Harper KT, Ginsburg KR, et al. Menstrual irregularity from hormonal contraception: a cause of reproductive health concerns in minority adolescent young women. Contraception. 2006;74(3):214–219.
   PubMed Web of Science ®Google Scholar
• Guillebaud J. Intrauterine contraception – what now and what next? Eur J Contracept Reprod Health Care. 2001;6(Suppl 1):11–14.
   Google Scholar
• Silva-Filho AL, Lira J, Rocha AL, et al. Non-hormonal and hormonal intrauterine contraception: survey of patients’ perceptions in four Latin American countries. Eur J Contracept Reprod Health Care. 2016;21(3):213–219.
   PubMed Web of Science ®Google Scholar
• Chang T, Moniz MH, Plegue MA, et al. Patient or clinician: duration of use of intrauterine devices based on who initiated discussion of placement. J Am Board Fam Med. 2016;29(1):24–28.
   PubMed Web of Science ®Google Scholar
• Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception. 1994;49(1):56–72.
   PubMed Web of Science ®Google Scholar
• 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. 2012;97(3):616-22.e1-3.
   PubMed Web of Science ®Google Scholar
• Nelson A, Apter D, Hauck B, et al. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol. 2013;122(6):1205–1213.
   PubMed Web of Science ®Google Scholar
• Gemzell-Danielsson K, Buhling KJ, Dermout SM, et al. A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents. Contraception. 2016;93(6):507–512.
   PubMed Web of Science ®Google Scholar
• NIH state-of-the-science conference statement on management of menopause-related symptoms. NIH Consens State Sci Statements. 2005;22(1):1–38. ​
   Google Scholar
• Apter D, Gemzell-Danielsson K, Hauck B, et al. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014;101(6):1656-62.e1-4.
   PubMed Web of Science ®Google Scholar
• Natavio MF, Taylor D, Lewis RA, et al. Temporal changes in cervical mucus after insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2013;87(4):426–431.
   PubMed Web of Science ®Google Scholar
• Lewis RA, Taylor D, Natavio MF, et al. Effects of the levonorgestrel-releasing intrauterine system on cervical mucus quality and sperm penetrability. Contraception. 2010;82(6):491–496.
   PubMed Web of Science ®Google Scholar
• Moraes LG, Marchi NM, Pitoli AC, et al. Assessment of the quality of cervical mucus among users of the levonorgestrel-releasing intrauterine system at different times of use. Eur J Contracept Reprod Health Care. 2016;21(4):318–322.
   PubMed Web of Science ®Google Scholar
• FDA highlights of prescribing information. Full prescribing information. NDA 208224 Kyleena. FDA approved 16 Sept. 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208224s000lbl.pdf.
   Google Scholar
• Gemzell-Danielsson K, Apter D, Dermout S, et al. Evaluation of a new, low-dose levonorgestrel intrauterine contraceptive system over 5 years of use. Eur J Obstet Gynecol Reprod Biol. 2017;210:22–28. ​
   Web of Science ®Google Scholar
• Gemzell-Danielsson K, Apter D, Hauck B, et al. The effect of age, parity and body mass index on the efficacy, safety, placement and user satisfaction associated with two low-dose levonorgestrel intrauteine contraceptive systems: subgroup analyses of data from a Phase III trial. Plos One. 2015;10(9):e0135309.
   PubMed Web of Science ®Google Scholar
• Heinemann K, Reed S, Moehner S, et al. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
   PubMed Web of Science ®Google Scholar
• Nahum GG, Kaunitz AM, Rosen K, et al. Ovarian cysts: presence and persistence with use of a 13.5mg levonorgestrel-releasing intrauterine system. Contraception. 2015 May;91(5):412–417.
   PubMed Web of Science ®Google Scholar
• United States Medical Eligibility Criteria (US MEC) for contraceptive use, 2016. [cited 2017 Jun 14]. Available at: https://www.cdc.gov/reproductivehealth/contraception/usmec.htm. ​
   Google Scholar
• World Health Organization (WHO) medical eligibility criteria for contraceptive use. 5th edition. 2015. Available at: http://who.int/reproductivehealth/publications/family_planning/MEC-5/en/. ​
   Google Scholar
• Shaamash AH, Sayed GH, Hussien MM, et al. A comparative study of the levonorgestrel-releasing intrauterine system Mirena versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development. Contraception. 2005;72(5):346–351.
   PubMed Web of Science ®Google Scholar
• ACOG Committee opinion No 672: clinical challenges of long-acting reversible contraceptive methods. Obstet Gynecol. 2016;128(3):e69–77. ​
   PubMed Web of Science ®Google Scholar
• AAP Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014;134(4):e1244–56. ​
   PubMed Web of Science ®Google Scholar
• Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998–2007.
   PubMed Web of Science ®Google Scholar
• CDC US Selected Practice Recommendations for contraceptive use, 2016. MMWR. 2016;65:7–18. ​
   Google Scholar
• WHO selected practice recommendations for contraceptive use. 2nd Edition. 2004. [cited 2017 Jun 14]. Available at: http://www.who.int/reproductivehealth/publications/family_planning/9241562846index/en/. ​
   Google Scholar
• Heikinheimo O, Inki P, Schmelter T, et al. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5 year study. Hum Reprod. 2014;29(6):1182–1188.
   PubMed Web of Science ®Google Scholar
• Teal SB, Westhoff CL, Keder LM, et al. Bleeding patterns in women using Liletta, a new 52 mg levonorgestrel-releasing intrauterine system, for up to 2 years. Contraception. 2015;92:359–414.
   Web of Science ®Google Scholar
• Madden T, McNicholas C, Zhao Q, et al. Association of age and parity with intrauterine device expulsion. Obstet Gynecol. 2014;124(4):718–726.
   PubMed Web of Science ®Google Scholar
• Murphy MK, Burke PJ, Haider S. A qualitative application of diffusion of innovations to adolescents’ perceptions of long-acting reversible contraception’s attributes. J Pediatr Adolesc Gynecol. 2016 Nov. pii:S1083-3188(16)30277-7. ​
   Web of Science ®Google Scholar