A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase II/III Clinical Study to Explore the Optimal Therapeutic Dose of SHR7280 Tablets and the Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia for Uterine Fibroids
Phase II:To explore the optimal effective dose of SHR7280 tablets in subjects with menorrhagia with uterine fibroids as a phase III treatment dose. Phase III:To evaluate the efficacy of the selected dose of SHR7280 compared with placebo in reducing menstrual bleeding in subjects with menorrhagic uterine fibroids in phase II studies.
• The informed consent has been signed and dated;
• Non-menopausal women between the ages of 18 and 49 (including 18 and 49);
• Single or multiple uterine fibroids were confirmed by ultrasound examination during screening, and the maximum diameter of at least one fibroid was ≥2 cm;
• Heavy menstrual bleeding measured by the alkaline hematin method during screening;
• 3 months before screening, the subject's menstrual cycle is 21-38 days, and the period is no more than 14 days;
• The pregnancy test was negative on the day of screening visit and randomization;
• Human papillomavirus (HPV) testing should be added for subjects who have cervical cytology at the time of screening visit and whose TCT results are atypical squamous cells (ASC-US) of uncertain significance, or who test negative for high-risk HPV.