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This investigational combination therapy consists of levonorgestrel (1.5 mg), a synthetic progestin, and piroxicam (40 mg), a non-steroidal anti-inflammatory drug (NSAID). Developed by the University of Utah for emergency contraception, the combination aims to improve the efficacy of standard levonorgestrel-only regimens. Levonorgestrel primarily works by delaying or inhibiting ovulation. Piroxicam, a cyclooxygenase (COX) inhibitor, provides a synergistic effect by blocking prostaglandin synthesis, which is essential for various reproductive processes including follicular rupture, fertilization, and embryo implantation. Clinical data from a Phase 3 trial in Hong Kong demonstrated significantly higher pregnancy prevention rates (95%) compared to levonorgestrel alone (63%), prompting further evaluation in a U.S.-based Phase 3 randomized controlled trial.
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