Mawet M. et al., 2014, Impact of a new levonorgestrel intrauterine system, Levosert ® , on heavy menstrual bleeding results of a one-year randomised controlled trial..pdf
Cote I , Jacobs P , Cumming D C . Use of health services associated with increased menstrual loss in the United States . Am J Obstet Gynecol 2003 ; 188 : 343-8.
Santer M , Warner P , Wyke S . A Scottish postal survey suggested that the prevailing clinical preoccupation with heavy periods does not refl ect the epidemiology of reported symptoms and problems . J Clin Epidemiol 2005 ; 58 : 1206-10.
Coulter A, Bradlow J, Agass M, et al. Outcomes of referrals to gynaecology outpatient clinics for menstrual problems: An audit of general practice records . Br J Obstet Gynaecol 1991 ; 98 : 789-96.
Bradlow J, Coulter A , Brooks P . Patterns of referral: A study of referrals to outpatient clinics from general practices in the Oxford Region . Oxford: Health Services Research Unit 1992.
Cole S K, Billewicz W Z, Thomson A M. Sources of variation in menstrual blood loss . J Obstet Gynaecol Br Commonw 1971 ; 78 : 933-9.
Janssen C A, Scholten P C, Heintz A P. Reconsidering menorrhagia in gynecological practice. Is a 30-year-old definition still valid? Eur J Obstet Gynecol Reprod Biol 1998 ; 78 : 69-72.
Hallberg L, Hogdahl A M, Nilsson L, et al. Menstrual blood loss-A population study. Variation at different ages and attempts to define normality . Acta Obstet Gynecol Scand 1966 ; 45 : 320-51.
Warner PE , Critchley HO, Lumsden MA, et al. Menorrhagia I: Measured blood loss, clinical features, and outcome in women with heavy periods: A survey with follow-up data . Am J Obstet Gynecol 2004 ; 190 : 1216-23.
Munro MG, Critchley HO, Broder MS, e t al. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age . Int J Gynaecol Obstet 2011 ; 113 : 3-13.
Edlund M . Nonhormonal treatments for heavy menstrual bleeding . J Womens Health (Larchmt) 2011 ; 20 : 1645-53.
Kaunitz AM, Bissonnette F, Monteiro I , et al. Levonorgestrel- releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: A randomized controlled trial . Obstet Gynecol 2010 ; 116 : 625-32.
Kaunitz AM, Meredith S, Inki P, et al. Levonorgestrelreleasing intrauterine system and endometrial ablation in heavy menstrual bleeding: A systematic review and meta-Analysis . Obstet Gynecol 2009 ; 113 : 1104-16.
Kucuk T , Ertan K . Continuous oral or intramuscular medroxyprogesterone acetate versus the levonorgestrel releasing intrauterine system in the treatment of perimenopausal menorrhagia: A randomized, prospective, controlled clinical trial in female smokers . Clin Exp Obstet Gynecol 2008 ; 35 : 57-60.
Irvine G A , C ampbell-Brown M B, L umsden M A, et a l. Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia . Br J Obstet Gynaecol 1998 ; 105 : 592-8.
Lethaby A E , C ooke I , R ees M . P rogesterone or progestogen- releasing intrauterine systems for heavy menstrual bleeding . Cochrane Database Syst Rev 2005 : CD002126.
International Conference in Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use . ICH Harmonised Tripartite Guideline Pharmaceutical Development Q8(R2). August 2009. Accessed 13 January 2014 from: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/ Quality/Q8-R1/Step4/Q8-R2-Guideline.pdf
Code of Federal Regulation. Part 820 Quality System Regulation-Section 820.30 Design Controls . 2013. 18-10-2013.
Wyatt KM, Dimmock PW, Walker TJ, et al. Determination of total menstrual blood loss . Fertil Steril 2001 ; 76 : 125-31.
Stép hanie R, Labied S, Blacher S, e t al. Endometrial vessel maturation in women exposed to levonorgestrelreleasing intrauterine system for a short or prolonged period of time . Hum Reprod 2007 ; 22 : 3084-91.
Xiao B , Wu S C, Chong J , et a l. Therapeutic effects of the levonorgestrel-releasing intrauterine system in the treatment of idiopathic menorrhagia . Fertil Steril 2003 ; 79 : 963-9.
Kriplani A , Singh B M, Lal S , et a l. Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia . Int J Gynaecol Obstet 2007 ; 97 : 190-4.
Shaw RW, S ymonds IM , T amizian O, et al. R andomised comparative trial of thermal balloon ablation and levonorgestrel intrauterine system in patients with idiopathic menorrhagia . Aust N Z J Obstet Gynaecol 2007 ; 47 : 335-40.
Barrington JW, Arunkalaivanan AS, Abdel-Fattah M. Comparison between the levonorgestrel intrauterine system (LNG-IUS) and thermal balloon ablation in the treatment of menorrhagia . Eur J Obstet Gynecol Reprod Biol 2003 ; 108 : 72-4.
Mercorio F , De S R, Di Spiezio S A, et a l. The effect of a levonorgestrel-releasing intrauterine device in the treatment of myoma-related menorrhagia . Contraception 2003 ; 67 : 277-80.
Reid PC, Virtanen-Kari S. Randomised comparative trial of the levonorgestrel intrauterine system and mefenamic acid for the treatment of idiopathic menorrhagia: A multiple analysis using total menstrual fl uid loss, menstrual blood loss and pictorial blood loss assessment charts . BJOG 2005 ; 112 : 1121-5.
Fedele L , B ianchi S, R affaelli R , e t al. T reatment of adenomyosis- associated menorrhagia with a levonorgestrelreleasing intrauterine device . Fertil Steril 1997 ; 68 : 426-9.
Busfield R A, Farquhar C M, Sowter M C, et a l. A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding . BJOG 2006 ; 113 : 257-63.
Crosignani PG, Vercellini P, M osconi P, e t a l. Levonorgestrel- releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding . Obstet Gynecol 1997 ; 90 : 257-63.
Grigorieva V, Chen-Mok M, Tarasova M, e t al. Use of a levonorgestrel-releasing intrauterine system to treat bleeding related to uterine leiomyomas . Fertil Steril 2003 ; 79 : 1194-8.
Rauramo I , Elo I , Istre O . Long-Term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection . Obstet Gynecol 2004 ; 104 : 1314-21.
Milman N, Clausen J, Byg KE . Iron status in 268 Danish women aged 18-30 years: influence of menstruation, contraceptive method, and iron supplementation . Ann Hematol 1998 ; 77 : 13-9.
Heikkila M, Nylander P, Luukkainen T. Body iron stores and patterns of bleeding after insertion of a levonorgestrel- or a copper-releasing intrauterine contraceptive device . Contraception 1982 ; 26 : 465-74.
Hurskainen R, Teperi J , Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: Randomized trial 5-year follow-up . JAMA 2004 ; 291 : 1456-63.
New intrauterine device now is in research. Contraceptive Technology Update 2013 . Accessed 13 January 2014 from: http://connection.ebscohost.com/c/ articles/90130176/new-intrauterine-device-now-research