Journal Article Summary
The article investigates the bioequivalence and adhesion properties of a new transdermal contraceptive patch using a different adhesive component at the end of its shelf life, compared to the currently marketed EVRA patch at the beginning of its shelf life. This research is significant because the adhesive component of the EVRA patch has been discontinued, necessitating a replacement that maintains the patch's effectiveness and safety. Understanding whether the new patch performs similarly to the original is crucial for ensuring continued access to effective contraceptive options for women.
In this study, 68 healthy women participated in a randomized, double-blind, two-way crossover trial. Each participant used both the test patch (with the new adhesive) and the reference patch (the original) over two treatment periods, separated by a washout phase. The results showed that the new patch was bioequivalent to the reference patch, with similar plasma concentrations of the hormones norelgestromin and ethinyl estradiol. Additionally, adhesion rates were comparable, with both patches demonstrating good adherence throughout the treatment period.
However, the study has limitations, including a relatively small sample size and the potential for bias in adhesion assessments. While both patches were found to have low irritation potential and similar safety profiles, patients should still discuss any concerns about using the new patch with their healthcare provider. It is essential for individuals to understand how changes in contraceptive products may affect their treatment and to ensure they are using the most suitable option for their needs.
Medication Safety Note
This journal article summary is provided for educational purposes only and is not medical advice. Always consult a licensed healthcare professional before starting, stopping, or changing any medication.
Article Cited
- Sanga Madhu, Vaughan Subusola, Nangosyah Julius, Scholz Veronika, Fonseca Sergio. Randomized, double-blind, two-way crossover bioequivalence and adhesion study, in healthy women, of a transdermal contraceptive patch with a newly sourced adhesive component at the end of shelf life vs. the EVRA patch at the beginning of shelf life. International Journal of Clinical Pharmacology and Therapeutics 2022. DOI: 10.5414/CP204034. PMID: 34779392. PMCID: PMC8670371.
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