Abstract
PROPESSⓇ is composed of a hydrophilic polymer containing 10 mg of dinoprostone and the retrieval string; PROPESS is inserted so as to stick to the target area of the cervix, and able to penetrate the cervix by continuously releasing dinoprostone. The pharmacokinetics, safety, and tolerability of PROPESS vaginal inserts 10 mg（dinoprostone vaginal insert） were evaluated in a phase I trial（228） in Japanese and non-Japanese women; the efficacy and safety were evaluated in multicenter, open-label, phase III trials（261 and 262）. In January 2020, PROPESS was approved for the indication of “initiation of cervical ripening in patients after 37 completed weeks of gestation”. PROPESS has been used appropriately in accordance with the risk management in the drug risk management plan and the guidelines for obstetrical practice by the Japan Society of Obstetrics and Gynecology and the Japan Association of Obstetricians and Gynecologists 2023 edition. The results of clinical research have also been reported.
