Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive

Contraception

Volumn 89, Issue 4, 2014, Pages 299-306

  Portman, David J ^a   Kaunitz, Andrew M ^b   Howard, Brandon ^c   Weiss, Herman ^d   Hsieh, Jennifer ^e   Ricciotti, Nancy ^e  

^a Columbus Center for Women's Health Research ^*  (United States)

^b UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^c Teva Global Medical Affairs   (United States)

^d Teva Global Medical Affairs   (Israel)

^e Teva Branded Pharmaceutical Products R and D Inc   (United States)

Author keywords

Bleeding; Contraception; Low dose; Spotting

Indexed keywords

ETHINYLESTRADIOL PLUS LEVONORGESTREL; ESTROGEN; ETHINYLESTRADIOL; LEVONORGESTREL; ORAL CONTRACEPTIVE AGENT;

ACNE; ADULT; ARTICLE; BACKACHE; CONTRACEPTIVE BEHAVIOR; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSMENORRHEA; FEMALE; HEADACHE; HUMAN; LIFE TABLE; MAJOR CLINICAL STUDY; MENORRHAGIA; METRORRHAGIA; MULTICENTER STUDY; NAUSEA; ORAL CONTRACEPTION; PHASE 3 CLINICAL TRIAL; PREGNANCY RATE; RHINOPHARYNGITIS; SEXUAL BEHAVIOR; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VAGINA BLEEDING; WEIGHT GAIN; YOUNG ADULT; HORMONAL CONTRACEPTION; PATIENT COMPLIANCE; PREGNANCY; SPOTTING; TREATMENT DURATION; CLINICAL TRIAL; DRUG EFFECTS; MENSTRUAL CYCLE; TREATMENT OUTCOME;

ADULT; CONTRACEPTIVES, ORAL, COMBINED; ESTROGENS; ETHINYL ESTRADIOL; FEMALE; HUMANS; LEVONORGESTREL; MENSTRUAL CYCLE; PREGNANCY; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84897114522     PISSN: 00107824     EISSN: 18790518     Source Type: Journal    
DOI: 10.1016/j.contraception.2014.01.013     Document Type: Article

References (35)

1. A. Edelman, R. Lew, C. Cwiak, M. Nichols, and J. Jensen Acceptability of contraceptive-induced amenorrhea in a racially diverse group of US women Contraception 75 2007 450 453
2. A.M. Kaunitz Menstruation: choosing whether...and when Contraception 62 2000 277 284
3. P.J. Sulak Preferences in oral contraceptive regimens and menstrual frequency Female Patient 32 Suppl. 2007 1 2
4. R. Snow, E. Hardy, E. Kneuper, E.M. Hebling, and G. Hall Women's responses to menses and nonbleeding intervals in the USA, Brazil and Germany Contraception 76 2007 23 29
5. L.C. Andrist, R.D. Arias, and D. Nucatola et al. Women's and providers' attitudes toward menstrual suppression with extended use of oral contraceptives Contraception 70 2004 359 363
6. A. Szarewski, A. von Stenglin, and S. Rybowski Women's attitudes towards monthly bleeding: results of a global population-based survey Eur J Contracept Reprod Health Care 17 2012 270 283
7. Female OB/GYNs speak out about health practices AWHONN Lifelines 8 2004 14 18
8. F.D. Anderson, and H. Hait A multicenter, randomized study of an extended cycle oral contraceptive Contraception 68 2003 89 96
9. F.D. Anderson, W. Gibbons, and D. Portman Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol Contraception 73 2006 229 234
10. R. Kroll, K.Z. Reape, and M. Margolis The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol Contraception 81 2010 41 48
11. A.B. Edelman, M.F. Gallo, J.T. Jensen, M.D. Nichols, K.F. Schulz, and D.A. Grimes Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception Cochrane Database Syst Rev 2005 CD004695 CD
12. J.M. Foidart, P.J. Sulak, I. Schellschmidt, and D. Zimmermann The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days Contraception 73 2006 34 40
13. I. Wiegratz, S. Stahlberg, and T. Manthey et al. Effect of extended-cycle regimen with an oral contraceptive containing 30 mcg ethinylestradiol and 2mg dienogest on bleeding patterns, safety, acceptance and contraceptive efficacy Contraception 84 2011 133 143
14. J.T. Jensen, S.G. Garie, D. Trummer, and J. Elliesen Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study Contraception 86 2012 110 118
15. F.H. Stewart, A.M. Kaunitz, K.D. LaGuardia, D.L. Karvois, A.C. Fisher, and A.J. Friedman Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial Obstet Gynecol 105 2005 1389 1396
16. K.Z. Reape, C.E. DiLiberti, C.H. Hendy, and E.J. Volpe Effects on serum hormone levels of low-dose estrogen in place of placebo during the hormone-free interval of an oral contraceptive Contraception 77 2008 34 39
17. J. Endrikat, C. Gerlinger, and K. Plettig et al. A meta-analysis on the correlation between ovarian activity and the incidence of intermenstrual bleeding during low-dose oral contraceptive use Gynecol Endocrinol 17 2003 107 114
18. W.D. Schlaff, A.M. Lynch, H.D. Hughes, M.I. Cedars, and D.L. Smith Manipulation of the pill-free interval in oral contraceptive pill users: the effect on follicular suppression Am J Obstet Gynecol 190 2004 943 951
19. M.A. Vandever, T.J. Kuehl, and P.J. Sulak et al. Evaluation of pituitary-ovarian axis suppression with three oral contraceptive regimens Contraception 77 2008 162 170
20. A.M. Kaunitz, D.J. Portman, H. Hait, and K.Z. Reape Adding low-dose estrogen to the hormone-free interval: impact on bleeding patterns in users of a 91-day extended regimen oral contraceptive Contraception 79 2009 350 355
21. B. Carr, J. Gersten, B. Howard, and H. Weiss Bleeding patterns with three ascending-dose, extended-cycle oral contraceptives (OCs) vs Seasonale® (abstract) Presented at the 61st Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, May 4-8 2013 New Orleans, LA
22. Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) [prescribing information] 2013 Teva Pharmaceuticals USA, Inc Sellersville, PA
23. D.R. Mishell Jr., J. Guillebaud, and C. Westhoff et al. Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials Contraception 75 2007 11 15
24. Lybrel (90 mcg levonorgestrel and 20 mgp ethinyl estradiol) tablets [prescribing information] 2010 Wyeth Pharmaceuticals Inc Philadelphia
25. J. Trussell, and D. Portman The creeping pearl: why has the rate of contraceptive failure increased in clinical trials of combined hormonal contraceptive pills? Contraception 88 2013 604 610
26. U.S. Food and Drug Administration and Advisory Committee for Reproductive Health Drugs FDA Briefing Document. General Meeting, January 23-24 2007
27. A. Poindexter, K.Z. Reape, and H. Hait Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo Contraception 78 2008 113 119
28. G. Plu-Bureau, L. Maitrot-Mantelet, J. Hugon-Rodin, and M. Canonico Hormonal contraceptives and venous thromboembolism: an epidemiological update Best Pract Res Clin Endocrinol Metab 27 2013 25 34
29. B.H. Stegeman, M. de Bastos, and F.R. Rosendaal et al. Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis BMJ 347 2013 f5298
30. Vlieg A. van Hylckama, F.M. Helmerhorst, J.P. Vandenbroucke, C.J.M. Doggen, and F.R. Rosendaal The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study BMJ 339 2009 b2921
31. A.M. Kaunitz Efficacy, cycle control, and safety of two triphasic oral contraceptives: Cyclessa™ (desogestrel/ethinyl estradiol) and ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol) a randomized clinical trial Contraception 61 2000 295 302
32. D.F. Archer, J.T. Jensen, J.V. Johnson, H. Borisute, G.S. Grubb, and G.D. Constantine Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results Contraception 74 2006 439 445
33. M.Y. Hou, S. Hurwitz, E. Kavanagh, J. Fortin, and A.B. Goldberg Using daily text-message reminders to improve adherence with oral contraceptives: a randomized controlled trial Obstet Gynecol 116 2010 633 640
34. A.M. Kaunitz, D. Portman, and C.L. Westhoff et al. Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial Obstet Gynecol 123 2 Pt 1 2014 295 303
35. C.L. Westhoff, A.T. Torgal, E.R. Mayeda, N. Shimoni, F.Z. Stanczyk, and M.C. Pike Predictors of noncompliance in an oral contraceptive clinical trial Contraception 85 2012 465 469