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This investigational combination therapy consists of a pretreatment with the small molecule progesterone receptor modulator mifepristone followed by the insertion of the Mirena levonorgestrel-releasing intrauterine system (LNG-IUS). Developed by researchers at the Karolinska Institutet, the regimen is designed to optimize bleeding patterns in women initiating Mirena for contraception. Mifepristone acts as a competitive antagonist at the progesterone receptor, potentially stabilizing the endometrial lining before the introduction of the progestin-releasing device. Mirena provides continuous local delivery of levonorgestrel, a synthetic progestin, to the endometrium to maintain contraception and endometrial suppression. The combination was specifically evaluated in a Phase 2 clinical trial to determine if mifepristone pretreatment could reduce the incidence of irregular vaginal bleeding and spotting typically experienced during the initial three months of LNG-IUS use.
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