Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill

Contraception

Volumn 91, Issue 3, 2015, Pages 204-210

  Kaunitz, Andrew M ^a   Portman, David ^b   Westhoff, Carolyn L ^c   Archer, David F ^d   Mishell, Daniel R ^e   Foegh, Marie ^f  

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

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

^c Department of Medicine   (United States)

^d EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^e UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^f NEW YORK MEDICAL COLLEGE   (United States)

Author keywords

Combination oral contraceptive; Ethinyl estradiol; Levonorgestrel; Obesity; Patient diaries; Transdermal contraceptive patch

Indexed keywords

COMBINATION ORAL CONTRACEPTIVE; ETHINYLESTRADIOL; LEVONORGESTREL; ORAL CONTRACEPTIVE AGENT; UNCLASSIFIED DRUG; ETHINYLESTRADIOL PLUS LEVONORGESTREL;

ADULT; AGE DISTRIBUTION; ARTICLE; BODY MASS; CLINICAL ASSESSMENT; CLINICAL EVALUATION; COMPARATIVE STUDY; CONTRACEPTIVE PATCH; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; EDUCATIONAL STATUS; ETHNICITY; FEMALE; GROUPS BY AGE; HORMONAL CONTRACEPTION; HUMAN; INFORMATION PROCESSING; INTENTION TO TREAT ANALYSIS; LABORATORY TEST; LOW DRUG DOSE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OBESITY; OPEN STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PILL; POPULATION; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; YOUNG ADULT; ADOLESCENT; BLOOD; CLINICAL TRIAL; REPRODUCIBILITY; STATISTICS AND NUMERICAL DATA; TRANSDERMAL PATCH;

ADOLESCENT; ADULT; BODY MASS INDEX; CONTRACEPTIVES, ORAL, COMBINED; ETHINYL ESTRADIOL; FEMALE; HUMANS; LEVONORGESTREL; PATIENT COMPLIANCE; REPRODUCIBILITY OF RESULTS; SELF REPORT; TRANSDERMAL PATCH; YOUNG ADULT;

EID: 84923386605     PISSN: 00107824     EISSN: 18790518     Source Type: Journal    
DOI: 10.1016/j.contraception.2014.11.011     Document Type: Article

References (39)

1. L.J. Piccinino, and W.D. Mosher Trends in contraceptive use in the United States: 1982-1995 Fam Plann Perspect 30 1 1998 4 10
2. M.E. Pittman, G.M. Secura, J.E. Allsworth, J.B. Homco, T. Madden, and J.F. Peipert Understanding prescription adherence: pharmacy claims data from the Contraceptive CHOICE Project Contraception 83 4 2011 340 345
3. A.J. Jakimiuk, P.G. Crosignani, T. Chernev, V. Prilepskaya, P. Bergmans, and M. Von Poncet High levels of women's satisfaction and compliance with transdermal contraception: results from a European multinational, 6-month study Gynecol Endocrinol 27 10 2011 849 856
4. D.F. Archer, A. Bigrigg, G.H. Smallwood, G.A. Shangold, G.W. Creasy, and A.C. Fisher Assessment of compliance with a weekly contraceptive patch (Ortho Evra/Evra) among North American women Fertil Steril 77 2 Suppl. 2 2002 S27 S31
5. M.C. Audet, M. Moreau, W.D. Koltun, A.S. Waldbaum, G. Shangold, and A.C. Fisher Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial JAMA 285 18 2001 2347 2354
6. J.J. Frost, and J.E. Darroch Factors associated with contraceptive choice and inconsistent method use, United States, 2004 Perspect Sex Reprod Health 40 2 2008 94 104
7. A.M. Sharma Managing weighty issues on lean evidence: the challenges of bariatric medicine CMAJ 172 1 2005 30 31
8. A.B. Edelman, N.E. Carlson, G. Cherala, M.Y. Munar, R.L. Stouffer, and J.L. Cameron Impact of obesity on oral contraceptive pharmacokinetics and hypothalamic-pituitary-ovarian activity Contraception 80 2 2009 119 127
9. A.B. Edelman, G. Cherala, M.Y. Munar, B. Dubois, M. McInnis, and F.Z. Stanczyk Prolonged monitoring of ethinyl estradiol and levonorgestrel levels confirms an altered pharmacokinetic profile in obese oral contraceptives users Contraception 87 2 2013 220 226
10. L.M. Lopez, D.A. Grimes, M. Chen, C. Otterness, C. Westhoff, and A. Edelman Hormonal contraceptives for contraception in overweight or obese women Cochrane Database Syst Rev 4 2013 CD008452
11. C.L. Westhoff, A.H. Torgal, E.R. Mayeda, F.Z. Stanczyk, J.P. Lerner, and E.K. Benn Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial Obstet Gynecol 116 2 Pt 1 2010 275 283
12. National Institutes of Health Office of Extramural Research website. NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research - Amended Available at http://grants.nih.gov/grants/funding/women-min/guidelines-amended-10-2001.htm 2001 [Accessed October 15, 2012]
13. A.M. Kaunitz, D. Portman, C.L. Westhoff, D.F. Archer, D.R. Mishell, and A. Rubin Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial Obstet Gynecol 123 2 Pt 1 2014 295 303
14. H. Licea-Perez, S. Wang, C.L. Bowen, and E. Yang A semi-automated 96-well plate method for the simultaneous determination of oral contraceptives concentrations in human plasma using ultra performance liquid chromatography coupled with tandem mass spectrometry J Chromatogr B Analyt Technol Biomed Life Sci 852 1-2 2007 69 76
15. L.Z. Zhao, G.P. Zhong, H.C. Bi, L. Ding, Y. Deng, and S. Guan Determination of levonorgestrel in human plasma by liquid chromatography-tandem mass spectrometry method: application to a bioequivalence study of two formulations in healthy volunteers Biomed Chromatogr 22 5 2008 519 526
16. W.Z. Shou, X. Jiang, and W. Naidong Development and validation of a high-sensitivity liquid chromatography/tandem mass spectrometry (LC/MS/MS) method with chemical derivatization for the determination of ethinyl estradiol in human plasma Biomed Chromatogr 18 7 2004 414 421
17. 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 1 2010 41 48
18. F.D. Anderson, and H. Hait A multicenter, randomized study of an extended cycle oral contraceptive [erratum, Contraception 2004;69(2):175] Contraception 68 2 2003 89 96
19. A.M. Kaunitz, R.J. Garceau, M.A. Cromie, and Lunelle Study Group Comparative safety, efficacy, and cycle control of Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and Ortho-Novum® 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic) Contraception 60 4 1999 179 187
20. D.F. Archer, R. Maheux, A. DelConte, F.B. O'Brien North American Levonorgestrel Study Group (NALSG) A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms Contraception 55 3 1997 139 144
21. 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 5 2013 604 610
22. D.F. Archer, V. Cullins, G.W. Creasy, and A.C. Fisher The impact of improved compliance with a weekly contraceptive transdermal system (Ortho Evra®) on contraceptive efficacy Contraception 69 3 2004 189 195
23. Nordette®-28 (levonorgestrel and ethinyl estradiol tablets, 0.15 mg/0.03 mg). Revised June 2013. Available at http://www.drugs.com/pro/nordette.html. Accessed December 18, 2014
24. Center for Drug Evaluation and Research New Drug Application 21-840 Seasonique Clinical Pharmacology and Biopharmaceutical Review 2006
25. Center for Drug Evaluation and Research New Drug Application 21-522 Seasonale Clinical Pharmacology and Biopharmaceutical Review 2003
26. Center for Drug Evaluation and Research New Drug Application 20-860 Levlite Clinical Pharmacology and Biopharmaceutical Review 1996
27. Data on file Agile Therapeutics, Inc Study ATI-CL12 and ATI-CL13 2012
28. D.J. Portman, A.M. Kaunitz, B. Howard, H. Weiss, J. Hsieh, and N. Ricciotti Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive Contraception 89 4 2014 299 306
29. LYBREL® (90 mcg levonorgestrel and 20 mcg ethinyl estradiol). Revised October 2010. Available at http://labeling.pfizer.com/showlabeling.aspx?id=489. Accessed December 18, 2014.
30. 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 5 2012 465 469
31. S.C. Kalichman, and T. Grebler Stress and poverty predictors of treatment adherence among people with low-literacy living with HIV/AIDS Psychosom Med 72 8 2010 810 816
32. World Health Organization Adherence to long term therapies: evidence for action 2003 [Geneva, Switzerland. WHO website. Available at http://www.who.int/chp/knowledge/publications/adherence-report/en/. Accessed February 12, 2014]
33. C.L. Ogden, M.M. Lamb, M.D. Carroll, and K.M. Flegal Obesity and socioeconomic status in adults: United States, 2005-2008 NCHS Data Brief 50 2010 1 8
34. C.L. Ogden, M.D. Carroll, B.K. Kit, and K.M. Flegal Prevalence of obesity in the United States, 2009-2010 NCHS Data Brief 82 2012 1 8
35. M.J. Rosenberg, M.S. Waugh, and S. Long Unintended pregnancies and use, misuse and discontinuation of oral contraceptives J Reprod Med 40 5 1995 355 360
36. D.F. Archer, F.Z. Stanczyk, A. Rubin, and D.R. Mishell Ovarian activity in obese and nonobese women treated with three transdermal contraceptive patches delivering three different doses of ethinyl estradiol and levonorgestrel Contraception 87 2 2013 201 211
37. C.L. Westhoff, I. Reinecke, K. Bangerter, and M. Merz Impact of body mass index on suppression of follicular development and ovulation using a transdermal patch containing 0.55-mg ethinyl estradiol/2.1-mg gestodene: a multicenter, open-label, uncontrolled study over three treatment cycles Contraception 90 3 2014 272 279
38. S. Campo, N.M. Askelson, E.L. Spies, and M. Losch Ambivalence, communication and past use: understanding what influences women's intentions to use contraceptives Psychol Health Med 17 3 2012 356 365
39. J.A. Higgins, R.A. Popkin, and J.S. Santelli Pregnancy ambivalence and contraceptive use among young adults in the United States Perspect Sex Reprod Health 44 4 2012 236 243