Abstract
Introduction
AG200-15, an investigational transdermal contraceptive delivery system or patch, is designed to be a low-dose, non-daily, combined hormonal contraceptive option for women. In this phase 1 study, the in vivo adhesion of the AG200-15 patch was compared to Xulane®, the only contraceptive patch available in the USA.
Methods
This phase 1, randomized, open-label, single-dose, two-treatment, two-period crossover adhesion study compared the 7-day adhesion of the AG200-15 and Xulane contraceptive patches. Eighty-three women, ages 18 to 35 years old, with body mass index (BMI) ≥ 19 kg/m2 and < 35 kg/m2, and weight ≥ 48 kg and < 90 kg were enrolled. Trained study site personnel used a five-point scale to assess patch adhesion daily. A score of 0 reflected at least 90% adhesion; while a score of 4 represented complete detachment of the patch. The primary objective was to compare the adhesion properties of the two patches; AG200-15 would be considered statistically non-inferior to Xulane if the upper 95% confidence limit (CL) of the mean difference in adhesion scores was below + 0.15.
Results
The overall mean (standard deviation) scores for AG200-15 (N = 78) and Xulane (N = 77) were 0.14 (0.28) and 0.39 (0.40), respectively (lower scores on the adhesion scale indicate better adhesion). The study demonstrated a difference in mean adhesion scores of − 0.24, meeting the prespecified non-inferiority criterion by demonstrating a one-sided upper CL of − 0.16. Thus, the in vivo adhesion of AG200-15 was shown to be non-inferior to that of Xulane. Most subjects experienced no skin irritation at the application site for either patch and no serious adverse event was reported in the study.
Conclusion
The in vivo adhesion of AG200-15 is non-inferior to that of Xulane on the basis of the prespecified criterion of the upper bound of the one-sided 95% CL for the mean adhesion score difference being below + 0.15. Both patches were generally well tolerated.
Funding
Agile Therapeutics, Inc.
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References
Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. medical eligibility criteria for contraceptive use. MMWR Recomm Rep. 2016;65(3):1–103.
Assessing adhesion with transdermal and topical delivery systems for ANDAs guidance for industry. 2018. https://www.fda.gov/media/98634/download. Accessed 20 Aug 2019.
Acknowledgements
We thank the participants of the study.
Funding
TKL Research, Inc. conducted the investigation, which was funded by Agile Therapeutics, Inc. The study and the Rapid Service Fee were funded by the sponsor, Agile Therapeutics, Inc.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Disclosures
Terrance Ocheltree is a consultant for Agile Therapeutics, Inc. Janet Wittes is a consultant for Agile Therapeutics, Inc. Jessica Case is a consultant for Agile Therapeutics, Inc. Michael Tuley is an employee of TKL Research, Inc. Irina Krause is an employee of TKL Research, Inc. Joseph Chiodo III is an employee of Agile Therapeutics, Inc. Elizabeth I.O. Garner was an employee of Agile Therapeutics, Inc. during the time of study and is now an employee of ObsEva, Plan-les-Ouates, Switzerland.
Compliance with Ethics Guidelines
The study was conducted in compliance with the Declaration of Helsinki, 2018 International Conference of Harmonisation (ICH) Harmonised Tripartite Guidelines—Guideline for Good Clinical Practice. The protocol, informed consent form, and any materials (such as advertisements, subject information sheets, or descriptions of the study used to obtain informed consent) for this study were reviewed and approved by a duly constituted institutional review board (IntegReview).
Data Availability
The datasets generated during and/or analyzed during the current study may be available from the corresponding author upon request.
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Ocheltree, T., Wittes, J., Case, J. et al. Adhesion Evaluation of AG200-15: An Investigational Transdermal Contraceptive Delivery System. Adv Ther 36, 3381–3389 (2019). https://doi.org/10.1007/s12325-019-01108-z
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DOI: https://doi.org/10.1007/s12325-019-01108-z