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This investigational contraceptive intrauterine system (IUS) is being developed by the Population Council to address the common side effect of increased menstrual bleeding associated with traditional copper intrauterine devices (IUDs). The device combines the spermicidal and inflammatory contraceptive effects of copper with the controlled, low-dose release of ulipristal acetate (UPA), a selective progesterone receptor modulator (SPRM). By delivering UPA locally to the endometrium at doses (5, 20, or 40 μg/day) that do not typically suppress ovulation, the system aims to induce endometrial atrophy and significantly reduce bleeding days while maintaining contraceptive efficacy. Results from Phase 1 proof-of-concept studies have demonstrated a dose-dependent reduction in bleeding days with a low incidence of progesterone receptor modulator associated endometrial changes (PAEC).
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