Evaluation of menstrual bleeding patterns: A new proposal for a universal guideline based on the analysis of more than 4500 bleeding diaries

European Journal of Contraception and Reproductive Health Care

Volumn 12, Issue 3, 2007, Pages 203-211

  Gerlinger, C ^a   Endrikat, J ^b,c   Kallischnigg, G ^d   Wessel, J ^a,e  

^a BAYER PHARMA AG   (Germany)

^b Bayer Inc   (Canada)

^c SAARLAND UNIVERSITY   (Germany)

^d TECHNISCHE UNIVERSITÄT BERLIN   (Germany)

^e HUMBOLDT UNIVERSITY   (Germany)

Author keywords

Bleeding pattern; Cluster analysis; Contraceptive; Cycle control; Endometriosis; Guideline; Hormone replacement therapy

Indexed keywords

GESTAGEN; ORAL CONTRACEPTIVE AGENT; SEX HORMONE;

ARTICLE; CLUSTER ANALYSIS; MENSTRUATION; METHODOLOGY; PRIORITY JOURNAL;

CONTRACEPTIVE AGENTS, FEMALE; DATA INTERPRETATION, STATISTICAL; FEMALE; GUIDELINES AS TOPIC; HORMONE REPLACEMENT THERAPY; HUMANS; MEDICAL RECORDS; MENSTRUATION; MENSTRUATION DISTURBANCES; TIME FACTORS; WORLD HEALTH ORGANIZATION;

EID: 34548303417     PISSN: 13625187     EISSN: 14730782     Source Type: Journal    
DOI: 10.1080/13625180701441121     Document Type: Article

References (37)

1. Taubert HD, Kuhl H. Kontrazeption mit Hormonen, Ein Leitfaden für die Praxis, 2nd edn. Stuttgart: Georg Thieme Verlag 1995:153-61.
2. Rosenberg MJ, Long SC. Oral contraceptives and cycle control: a critical review of the literature. Adv Contracept 1992;8(Suppl 1):35-45.
3. Roumen FJME, Apter D, Mulders TMT, Dieben TOM. Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod 2001;16:469-75.
4. Roumen F. Contraceptive efficacy and tolerability with a novel combined contraceptive vaginal ring, NuvaRing. Eur J Contracept Reprod Health Care 2002;7(Suppl 2):19-24.
5. Roumen FJME, op ten Berg MMT, Hoomans EHM. The combined contraceptive vaginal ring (NuvaRing®): first experience in daily clinical practice in the Netherlands. Eur J Contracept Reprod Health Care 2006;11:14-22.
6. Archer D, Raine T, Darney P, Alexander NJ. An open-label noncomparative study to evaluate the vagina and cervix of NuvaRing® users [Abstract O-65]. Fertil Steril 2002;78(Suppl 1):S25.
7. Oddsson K, Leifels Fischer B, et al. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraception 2005;71:176-82.
8. Archer DF, Cullins V, Creasy GW, Fisher AC. The impact of improved compliance with a weekly contraceptive transdermal system (Ortho Evra) on contraceptive efficacy. Contraception 2004;69:189-95.
9. Heger-Mahn D, Warlimont C, Faustmann T, et al. Combined ethinylestradiol/gestodene contraceptive patch: two-center, open-label study of ovulation inhibition, acceptability and safety over two cycles in female volunteers. Eur J Contracept Reprod Health Care 2004;9:173-81.
10. Ladipo OA, Akinso SA. Contraceptive implants. Afr J Reprod Health 2005;9:16-23.
11. Luukkainen T, Allonen H, Haukkamaa M, et al. Five years' experience with levonorgestrel-releasing IUDs. Contraception 1986;33:139-48.
12. Andersson K. The levonorgestrel intrauterine system: more than a contraceptive. Eur J Contracept Reprod Health Care 2001;6(Suppl 1):15-22.
13. Sivin I, Stern J, Coutinho E, et al. Prolonged intrauterine contraception. A seven-year randomized study of the levonorgestrel 20 mcg/day (LNg20) and the copper T380Ag IUDs. Contraception 1991;44:473-80.
14. Draper BH, Morroni C, Hoffman M, et al. Depot medroxyprogesterone versus norethisterone oenanthate for long-acting progestogenic contraception. Cochrane Database Syst Rev 2006;19(3):CD005214.
15. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception 1987;36:37-53.
16. Batár I. State-of-the-art of intrauterine contraception. Eur J Contracept Reprod Health Care 2006;11:262-9.
17. Sulak PJ, Scow RD, Preece C, et al. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol 2000;95:261-6.
18. Wiegratz I, Hommel HH, Zimmermann T, Kuhl H. Attitude of German women and gynecologists towards long-cycle treatment with oral contraceptives. Contraception 2004;69:37-42.
19. Endrikat J, Cronin M, Gerlinger C, et al. Double-blind, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day vs. a 21-day low-dose oral contraceptive regimen containing 20 μg ethinylestradiol and 75 μg gestodene. Contraception 2001;64:99-105.
20. Sullivan H, Furniss H, Spona J, Elstein M. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 microg) and ethinyl estradiol (15 microg) on ovarian activity. Fertil Steril 1999;72:115-20.
21. YAZ® US label. Available at: http://www.fda.gov/cder/foi/label/2006/ 021676s000lbl.pdf (accessed 3 June 2007).
22. Anderson FD, Hait H. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception 2003;68:89-96.
23. The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on Clinical Evaluation of Steroid Contraceptives in Women, CPMP/EWP/519/98, Section 4.3. London: CPMP, 2000.
24. The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). Points to Consider on Hormone Replacement Therapy, CPMP/EWP/021/97, Section 2.2.2. London: CPMP, 1997.
25. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry. Labeling for Combined Oral Contraceptives Revision 1. Available at: http://www.fda.gov/cder/guidance/5197dft.pdf (accessed 3 June 2007).
26. URL. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?DB= pubmed (accessed 3 June 2007).
27. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. The analysis of vaginal bleeding patterns induced by fertility regulating methods. Contraception 1986;34:253-60.
28. Gerlinger C. Entwicklung zweier methodologischer Leitlinien zur Beurteilung von Blutungsmustern - Eine Hilfe für Zulassung und Verschreibung auf der Basis einer empirischen Analyse. Dissertation, Technische Universität Berlin, 2005.
29. Endrikat J, Cronin M, Gerlinger C, et al. Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 microg ethinyl estradiol and 75 microg gestodene and a 21-day regimen with 20 microg ethinyl estradiol and 150 microg desogestrel. Contraception 2001;64:201-7.
30. Schindler AE, Christensen B, Henkel A, et al. High-dose pilot study with the novel progestogen dienogest in patients with endometriosis. Gynecol Endocrinol 2006;22:9-17.
31. Archer DF, Pickar JH. The assessment of bleeding patterns in postmenopausal women during continuous combined hormone replacement therapy: a review of methodology and recommendations for reporting of the data. Climacteric 2002;5:45-59.
32. Mishell DR Jr, Guillebaud J, Westhoff C, et al. Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials. Contraception 2007;75:11-5.
33. Korver T, Klipping C, Heger-Mahn D, et al. Maintenance of ovulation inhibition with the 75-microg desogestrel-only contraceptive pill (Cerazette) after scheduled 12-h delays in tablet intake. Contraception 2005;71:8-13.
34. Vasilenko P, Kraicer PF, Kaplan R, et al. A new and simple method of measuring menstrual blood loss. J Reprod Med 1988;33:293-7.
35. Seasonale US label. Available at: http://www.fda.gov/cder/foi/label/2003/ 21544_seasonale_lbl.pdf (accessed 3 June 2007).
36. Mirena US label. Available at: http://www.berlex.com/html/products/pi/ Mirena_PI.pdf (accessed 3 June 2007).
37. Angeliq US Label. Available at: www.fda.gov/cder/foi/label/2005/ 021355lbl.pdf (accessed 3 June 2007).