The Patch Wear Profile from SECURE: A Once-Weekly Low-Dose Contraceptive Patch Study
ACOG ePoster. Nelson A. Apr 27, 2018; 211444; 7F
Anita Nelson
Anita Nelson
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Introduction: AG200-15 (Twirla®) is an investigational transdermal contraceptive delivery system (TCDS), which delivers daily exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) similar to oral doses of 120 μg LNG and 30 μg EE. We examine various aspects of patch adhesion and wearability with AG200-15 TCDS.

Methods: SECURE was a single-arm, open-label, Phase 3 study conducted in US women 18 years or older, with no restrictions on body mass index or weight ( NCT02158572). Subjects recorded patch-related characteristics daily in electronic diaries; irritation/itching and patch adhesion were also evaluated by the investigator at each visit. Irritation/itching scores were rated from 0 (none) to 3 (severe). Patch adhesion scores were rated from 0 (no/small amount of lifting off skin) to 4 (entire patch falling off).

Results: In 2031 women across 13 cycles, 6.2% reported a local site reaction. The subject-rated mean skin irritation/itching score was 1.31, and most women reported their worst skin irritation as none, mild, or moderate (26.2%, 32.0%, and 26.6%, respectively). The investigator-reported mean skin irritation score was 0.18, and most women were determined by the investigator to have none or mild skin irritation (85.0% and 12.6%, respectively). The mean subject- and investigator-rated patch adhesion scores were 0.52 and 0.04, respectively. Treatment discontinuation due to application site irritation/itching occurred in 1.9% of women.

Conclusion/Implications: Overall, results of various subject- and investigator-rated patch characteristics provide favorable support for patch adhesion and wearability of the AG200-15 TCDS.
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