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New Product Review (September 2003) Norelgestromin/ethinyl oestradiol transdermal contraceptive system (Evra®)

Abstract

This new transdermal contraceptive system (contraceptive patch), Evra® (Janssen-Cilag), received a UK product licence in 2003. In clinical trials:

  • Consistent doses of norelgestromin and ethinyl oestradiol are released into the systemic circulation daily. Pharmacokinetic data suggest that levels are sufficient to inhibit ovulation for at least 7 days.

  • The overall Pearl index for the contraceptive patch (1.24; 95% CI 0.19-2.33) was similar to that of a triphasic combined oral contraceptive (COC) pill (2.18; 95% CI 0.57-3.8).

  • Self-reported ‘perfect’ compliance was significantly better with the contraceptive patch (88.2%) than with a combined contraceptive pill (77.7%).

  • Patch detachment, requiring replacement with a new patch, with normal daily activity is uncommon (4.6%).

  • Breakthrough bleeding and spotting were significantly more common with the contraceptive patch than with combined oral contraception in the first two cycles but differences were not significant by cycle three.

  • In general, reported side effects were not significantly different with contraceptive patch or combined pill use. However, breast tenderness in the first two treatment cycles was more common with patch use. Symptoms were mild to moderate in 85% of women and were rarely treatment limiting.

  • Currently, there are limited data regarding risk of venous thromboembolism, and cervical or breast cancer with the contraceptive patch.

  • No clinically significant alterations in metabolic or haemostatic parameters were identified with contraceptive patch use. A month's supply of the contraceptive patch costs $7.74. Combined oral contraception prices range from approximately $0.80 to $5.00 and hormone replacement therapy patches range from $10.00 to $13.00. The contraceptive patch offers additional choice for women who wish to use a combined hormonal method of contraception.

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