Effect of extended-cycle regimen with an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on bleeding patterns, safety, acceptance and contraceptive efficacy

Contraception

Volumn 84, Issue 2, 2011, Pages 133-143

  Wiegratz, Inka ^a   Stahlberg, Skadi ^a   Manthey, Torsten ^a   Sänger, Nicole ^a   Mittmann, Katrin ^b   Lange, Evelyn ^b   Mellinger, Uwe ^b   Palombo Kinne, Ernesta ^b   Kuhl, Herbert ^a  

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^b BAYER PHARMA AG   (Germany)

Author keywords

Bleeding patterns; Cycle control; Dienogest; Ethinyl estradiol; Extended cycle regimen; Oral contraceptives

Indexed keywords

DIENOGEST PLUS ETHINYLESTRADIOL;

ADULT; ARTICLE; BLEEDING TIME; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG USE; EXTENDED CYCLE REGIMEN; FEMALE; HUMAN; HUMAN EXPERIMENT; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NORMAL HUMAN; ORAL CONTRACEPTION; PHASE 2 CLINICAL TRIAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SPOTTING; UTERINE BLEEDING PATTERN; VOLUNTEER;

ADULT; CONTRACEPTIVES, ORAL; ESTROGENS; ETHINYL ESTRADIOL; FEMALE; HUMANS; MENSTRUATION; NANDROLONE; PATIENT SATISFACTION; PROSPECTIVE STUDIES; YOUNG ADULT;

EID: 79960290998     PISSN: 00107824     EISSN: 18790518     Source Type: Journal    
DOI: 10.1016/j.contraception.2011.01.002     Document Type: Article

References (49)

1. Birtch R.L., Olatunbosun O.A., and Pierson R.A. Ovarian follicular dynamics during conventional vs. continuous oral contraceptive use Contraception 73 2006 235 243 (Pubitemid 43202172)
2. Spona J., Elstein M., and Feichtinger W. Shorter pill-free interval in combined oral contraceptives decreases follicular development Contraception 54 1996 71 77 (Pubitemid 26256707)
3. Sullivan H., Furniss H., Spona J., and Elstein M. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 mcg) and ethinyl estradiol (15 mcg) on ovarian activity Fertil Steril 72 1999 115 120 (Pubitemid 29300271)
4. Schlaff W., Lynch A.M., Hughes H.D., Cedars M.I., and Smith D.L. Manipulation of the pill-free interval in oral contraceptive pill users: the effect on follicular suppression Am J Obstet Gynecol 190 2004 943 951 (Pubitemid 38561509)
5. den Tonkelaar I., and Oddens B.J. Preferred frequency and characteristics of menstrual bleeding in relation to reproductive status, oral contraceptive use, and hormone replacement therapy use Contraception 59 1999 357 362 (Pubitemid 29430163)
6. Sulak P.J., Scow R.D., Preece C., Riggs M.W., and Kuehl T.J. Hormone withdrawal symptoms in oral contraceptive users Obstet Gynecol 95 2000 261 266 (Pubitemid 30045651)
7. Coffee A.L., Sulak P.J., and Kuehl T.J. Extended-term assessment of symptomatology and satisfaction of an extended oral contraceptive regimen Contraception 75 2007 444 449 (Pubitemid 46764300)
8. Henzl M.R., and Polan M.L. Avoiding menstruation. A review of health and lifestyle issues J Reprod Med 49 2004 162 174 (Pubitemid 38405780)
9. Wiegratz I., Kissler S., Kuhl H., and Kaufmann M. Extended and continuous use of hormonal contraceptives to reduce menstruation Women's Health 2 2006 705 716 (Pubitemid 44523880)
10. Edelman A., Lew R., Cwiak C., Nichols M., and Jensen J. Acceptability of contraceptive-induced amenorrhea in a racially diverse group of US women Contraception 75 2007 450 453 (Pubitemid 46764306)
11. Anderson F.D., Hait H. the Seasonale-301 Study Group A multicenter, randomized study of an extended cycle oral contraceptive Contraception 68 2003 89 96 (Pubitemid 37101032)
12. Miller L., Verhoeven C.H., and Hout J. Extended regimens of the contraceptive vaginal ring Obstet Gynecol 106 2005 473 482 (Pubitemid 41208778)
13. Anderson F.D., Gibbons W., and Portman D. Extended-term safety of an extended-cycle oral contraceptive (Seasonale): a 2-year multicenter open-label extension trial Am J Obstet Gynecol 195 2006 92 96 (Pubitemid 43927514)
14. Barreiros F.A., Guazzelli A.F., de Araujo F.F., and Barbosa R. Bleeding patterns of women using extended regimens of the contraceptive vaginal ring Contraception 75 2007 204 208 (Pubitemid 46217187)
15. Guazzelli C.A.F., Barreiros F.A., Barbosa R., de Araujo F.F., and Moron A.F. Extended regimens of the vaginal contraceptive ring: cycle control Contraception 80 2010 430 435
16. Miller L., and Hughes J.P. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial Obstet Gynecol 101 2003 653 661 (Pubitemid 36390051)
17. Archer D.F., Jensen J.T., Johnson J.V., Borisute H., Grubb G.S., and Constantine G.D. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results Contraception 74 2006 439 445 (Pubitemid 46037535)
18. IMS®-DPM Sales Analyzer, http://www.imshealth.de
19. Gerlinger C., Endrikat J., Kallischnigg G., and Wessel J. Evaluation of menstrual bleeding patterns: a new proposal for a universal guideline based on the analysis of more than 4500 bleeding diaries Eur J Contracept Reprod Health Care 12 2007 203 211 (Pubitemid 47347161)
20. European Medicines Agency (EMEA) Committee for medicinal products for human use (CHMP): guideline on clinical investigation of steroid contraceptives in women http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2009/09/WC500003349.pdf
21. Sabatini R., and Cagiano R. Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives Contraception 74 2006 220 223 (Pubitemid 44175362)
22. Anderson F.D., Gibbons W., and Portman D. Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol Contraception 73 2003 229 234
23. Hitchcock C.L., and Prior J.C. Evidence about extending the duration of oral contraceptive use to suppress menstruation Women's Health Issues 14 2004 201 211 (Pubitemid 39602746)
24. Kroll R., Reape K.Z., and Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol Contraception 81 2010 41 48
25. Bachman G., and Korner P. Bleeding patterns associated with oral contraceptive use: a review of the literature Contraception 76 2007 182 189 (Pubitemid 47260594)
26. Rosenberg M.J., and Waugh M.S. Oral contraception discontinuation: a prospective evaluation of frequency and reasons Am J Obstet Gynecol 179 1998 577 582 (Pubitemid 28447229)
27. Edelman A.B., Koontz S.L., Nichols M.D., and Jensen J.T. Continuous oral contraceptives. Are bleeding patterns dependent on the hormones given? Obstet Gynecol 107 2006 657 665
28. Barnhart K. Patient candidate evaluation for a low-dose continuous oral contraceptive Contraception 74 2006 192 (abstract 49)
29. Sulak P.J., Kuehl T.J., Coffee A., and Willis S.W. Prospective analysis of occurrence and management of breakthrough bleeding during an extended oral contraceptive regimen Am J Obstet Gynecol 195 2006 935 941 (Pubitemid 44415645)
30. Sulak P.J., Smith V., Coffee A., Witt I., Kuehl A.L., and Kuehl T.J. Frequency and management of breakthrough bleeding with continuous use of the transvaginal contraceptive ring Obstet Gynecol 112 2008 563 571
31. Anderson F.D., Hait H., Hsiu J., Thompson-Graves A.L., Wilborn W.H., and Williams R.F. Endometrial microstructure after extended-term use of a 91-day extended-cycle oral contraceptive regimen Contraception 71 2005 55 59 (Pubitemid 41583150)
32. Johnson J.V., Grubb G.S., and Constantine G.D. Endometrial histology following 1 year of a continuous daily regimen of levonorgestrel 90 mcg/ethinyl estradiol 20 mcg Contraception 75 2007 23 26 (Pubitemid 44854855)
33. Foidart J.M., Sulak P.J., Schellschmidt I., Zimmermann D. Yasmin Extended Regimen Study Group The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days Contraception 73 2006 34 40 (Pubitemid 41811186)
34. Wiegratz I., and Kuhl H. Extended-cycle treatment with oral contraceptives Drugs 64 2004 2447 2462
35. Willis S.A., Kuehl T.J., Spiekerman A.M., and Sulak P.J. Greater inhibition of the pituitary-ovarian axis in oral contraceptive regimens with a shortened hormone-free interval Contraception 74 2006 100 103 (Pubitemid 44062466)
36. de Bruijn S.F., Stam J., Vandenbroucke J.P. Cerebral Venous Sinus Thrombosis Study Group Increased risk of cerebral venous sinus thrombosis with third-generation oral contraceptives Lancet 351 1998 1404 (Pubitemid 28210002)
37. Sidney S., Petitti D.B., Soff G.A., Cundiff D.L., Tolan K.K., and Quesenberry C.P. Jr Venous thromboembolic disease in users of low-estrogen combined estrogen-progestin oral contraceptives Contraception 70 2004 3 10 (Pubitemid 38781972)
38. Lidegaard O., Lokkegaard E., Svendsen A.L., and Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study BMJ 339 2009 b2890 10.1136/bmj.b2890
39. Jung-Hoffmann C., and Kuhl H. Pharmacokinetics and pharmacodynamics of oral contraceptive steroids: factors influencing steroid metabolism Am J Obstet Gynecol 163 1990 2183 2197
40. Wiegratz I., Stahlberg S., and Manthey T. Effects of conventional or extended-cycle regimen of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on various hemostasis parameters Contraception 78 2008 384 391
41. Sänger N., Stahlberg S., and Manthey T. Effects of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on thyroid hormones and androgen parameters: conventional vs. extended-cycle use Contraception 77 2008 420 425
42. Wiegratz I., Stahlberg S., and Manthey T. Effects of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on carbohydrate metabolism during 1 year of conventional or extended-cycle use Horm Metab Res 42 2010 358 363
43. Wiegratz I., Stahlberg S., and Manthey T. Effects of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on lipid metabolism during 1 year of conventional or extended-cycle use Contraception 81 2010 57 61
44. Wu O., Robertson L., and Langhorne P. Oral contraceptives, hormone replacement therapy, thrombophilias and risk of venous thromboembolism: a systematic review. The TREATS Study Thromb Haemost 94 2005 17 25
45. Sulak P.J., Cressman B.E., Waldrop E., Holleman S., and Kuehl T.J. Extending the duration of active oral contraceptive pills to manage hormone withdrawal symptoms Obstet Gynecol 89 1997 179 183 (Pubitemid 27057203)
46. Edelman A., Gallo M.F., Nichols M.D., Jensen J.T., Schulz K.F., and Grimes D.A. Continuous versus cyclic use of combined oral contraceptives for contraception: systematic Cochrane review of randomized controlled trials Hum Reprod 21 2006 573 578 (Pubitemid 43372958)
47. Sulak P.J., Kuehl T.J., Ortiz M., and Shull B.L. Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms Am J Obstet Gynecol 186 2002 1142 1149 (Pubitemid 34665050)
48. Coffee A.L., Kuehl T.J., Willis S., and Sulak P.J. Oral contraceptives and premenstrual symptoms: comparison of a 21/7 and extended regimen Am J Obstet Gynecol 195 2006 1311 1319 (Pubitemid 44635376)
49. Sulak P.J., Willis S., Kuehl T., Coffee A., and Clark J. Headaches and oral contraceptives: impact of eliminating the standard 7-day placebo interval Headache 47 2007 27 37 (Pubitemid 46096054)