Skip to main content
SpringerLink
Log in

Effect of a Low-Dose Contraceptive Patch on Efficacy, Bleeding Pattern, and Safety: A 1-Year, Multicenter, Open-Label, Uncontrolled Study

  • Original Article
  • Published:
Reproductive Sciences Aims and scope Submit manuscript

Abstract

This Phase III, uncontrolled, open-label, multicenter study was conducted to investigate the contraceptive efficacy, bleeding pattern, and cycle control of a novel once-a-week contraceptive patch, delivering low-dose ethinyl estradiol (EE) and gestodene (GSD) at the same systemic exposure seen after oral administration of a combined oral contraceptive containing 0.02 mg EE/0.06 mg GSD. Participants were women aged 18 to 35 years, all of whom received the EE/GSD patch for 13 cycles each of 21 treatment days (one patch per week for 3 weeks) followed by a 7-day, patch-free interval. The primary efficacy variable was the occurrence of unintended pregnancies during the study period as assessed by life table analysis and the Pearl Index. Secondary efficacy variables were days with bleeding during four 90-day reference periods and during 1 treatment year, bleeding pattern, and cycle control. The Kaplan-Meier probability of contraceptive protection after 364 treatment days was 98.8% and the adjusted Pearl Index was 0.81. The percentage of participants with intracyclic bleeding/spotting decreased over time, from 11.4% to 6.8% in cycles 1 and 12, respectively. Almost all participants (range: 90.8%-97.6%) experienced withdrawal bleeding across the study period. Compliance was very high (mean: 97.9%; median: 100%). The most frequent adverse events were headache (9.5%) and application site reaction (8.5%); no clinically significant safety concerns were observed. Results suggest the EE/GSD patch is highly effective in preventing pregnancy. Menstrual bleeding pattern was favorable and within the ranges expected of a healthy female population. The patch was well tolerated and treatment compliance was high.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Nelson HD. Commonly used types of postmenopausal estrogen for treatment of hot flashes: scientific review. JAMA. 2004; 291(13):1610–1620.

    Article  CAS  Google Scholar 

  2. Janssen-Cilag. Evra® transdermal patch. Summary of Product Characteristics; 2012. http://www.medicines.org.uk/emc/medicine/12124/spc. Accessed April 17, 2014.

  3. Bayer. Apleek®. Summary of Product Characteristics. http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1394776320327.pdf. Accessed April 17, 2014.

  4. UN Department of Economic and Social Affairs Population Division. World contraceptive use. http://www.un.org/esa/population/publications/contraceptive2011/contraceptive2011.htm. Accessed April 17, 2014.

  5. Aubeny E, Buhler M, Colau JC, Vicaut E, Zadikian M, Childs M. The Coraliance study: non-compliant behavior. Results after a 6-month follow-up of patients on oral contraceptives. Eur J Contracept Reprod Health Care. 2004;9(4):267–277.

    Article  CAS  Google Scholar 

  6. Goldzieher JW, Brody SA. Pharmacokinetics of ethinyl estradiol and mestranol. Am J Obstet Gynecol. 1990;163(6 pt 2): 2114–2119.

    Article  CAS  Google Scholar 

  7. Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climacteric. 2005;(8 suppl 1): 3–63.

    Article  CAS  Google Scholar 

  8. Jung-Hoffmann C, Kuhl H. Intra- and interindividual variations in contraceptive steroid levels during 12 treatment cycles: no relation to irregular bleedings. Contraception. 1990;42(4):423–438.

    Article  CAS  Google Scholar 

  9. Burkman RT. Transdermal hormonal contraception: benefits and risks. Am J Obstet Gynecol. 2007;197(2):134 e131–e136.

    Article  Google Scholar 

  10. Heger-Mahn D, Warlimont C, Faustmann T, Gerlinger C, Klipping C. 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(3):173–181.

    Article  CAS  Google Scholar 

  11. Coelingh Bennink HJ. Are all estrogens the same? Maturitas. 2004;47(4):269–275.

    Article  CAS  Google Scholar 

  12. Barbosa IC, Filho CI, Faggion D Jr, Baracat EC. Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 microg and ethinylestradiol 15 microg (Minesse). Contraception. 2006;73(1):30–33.

    Article  CAS  Google Scholar 

  13. Kaplan B. Desogestrel, norgestimate, and gestodene: the newer progestins. Ann Pharmacother. 1995;29(7–8):736–742.

    Article  CAS  Google Scholar 

  14. Wilde MI, Balfour JA. Gestodene. A review of its pharmacology, efficacy and tolerability in combined contraceptive preparations. Drugs. 1995;50(2):364–395.

    Article  CAS  Google Scholar 

  15. Benagiano G, Primiero FM, Farris M. Clinical profile of contraceptive progestins. Eur J Contracept Reprod Health Care. 2004;9(3):182–193.

    Article  CAS  Google Scholar 

  16. Beligotti F, Gordon K. Findings from the International ‘I plan on . . . survey’: women’s awareness, misconceptions, and preferences regarding their contraceptive options. Eur J Contracept Reprod Health Care. 2012;17(S1):S98.

    Google Scholar 

  17. Glasier A, Scorer J, Bigrigg A. Attitudes of women in Scotland to contraception: a qualitative study to explore the acceptability of long-acting methods. J Fam Plann Reprod Health Care. 2008; 34(4):213–217.

    Article  Google Scholar 

  18. Schrager S. Abnormal uterine bleeding associated with hormonal contraception. Am Fam Physician. 2002;65(10):2073–2080.

    PubMed  Google Scholar 

  19. Jakimiuk AJ, Crosignani PG, Chernev T, et al. High levels of women’s satisfaction and compliance with transdermal contraception: results from a European multinational, 6-month study. Gynecol Endocrinol. 2011;27(10):849–856.

    Article  CAS  Google Scholar 

  20. Weisberg E. Developments in contraception. Expert Opin Pharmacother. 2014;15(2):203–210.

    Article  CAS  Google Scholar 

  21. Reid R, Leyland N, Wolfman W, et al. SOGC clinical practice guidelines: oral contraceptives and the risk of venous thromboembolism: an update. J Obstet Gynaecol Can. 2010;32(12):1192–1204.

    Article  Google Scholar 

  22. Vandenbroucke JP, Koster T, Briet E, Reitsma PH, Bertina RM, Rosendaal FR. Increased risk of venous thrombosis in oral contraceptive users who are carriers of factor V Leiden mutation. Lancet. 1994;344(8935):1453–1457.

    Article  CAS  Google Scholar 

  23. Bitzer J, Amy JJ, Beerthuizen R, et al. Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism. J Fam Plann Reprod Health Care. 2013; 39(3):156–159.

    Article  Google Scholar 

  24. Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007;109(2 pt 1):339–346.

    Article  Google Scholar 

  25. Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006; 73(3):223–228.

    Article  CAS  Google Scholar 

  26. Lidegaard O, Nielsen LH, Skovlund CW, Lokkegaard E. Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10. BMJ. 2012;344:e2990.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, MVZ Kinderwunschzentrum Wiesbaden GmbH, Wiesbaden, Germany

    Inka Wiegratz MD

  2. Faculty of Medicine of the Johann Wolfgang Goethe-University Frankfurt/Main, Germany

    Inka Wiegratz MD

  3. Department of Reproductive Biology, Biomedical Research Centre, University of Coahuila, Coahuila, Mexico

    Susana Bassol MD

  4. Sydney Centre for Reproductive Health Research, FPNSW and University of Sydney, Sydney, Australia

    Edith Weisberg MBBS

  5. Women’s Health, Bayer Pharma AG, Berlin, Germany

    Uwe Mellinger

  6. Women’s Health, Bayer Pharma AG, Müllerstr. 178, 13353, Berlin, Germany

    Martin Merz PhD

Authors
  1. Inka Wiegratz MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Susana Bassol MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Edith Weisberg MBBS
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Uwe Mellinger
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Martin Merz PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Martin Merz PhD.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Wiegratz, I., Bassol, S., Weisberg, E. et al. Effect of a Low-Dose Contraceptive Patch on Efficacy, Bleeding Pattern, and Safety: A 1-Year, Multicenter, Open-Label, Uncontrolled Study. Reprod. Sci. 21, 1518–1525 (2014). https://doi.org/10.1177/1933719114532840

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/1933719114532840

Keywords

Search

Navigation