A phase III confirmatory study of KLH-2109 in uterine fibroids patient with menorrhagia

Kissei Pharmaceutical Co., Ltd.0 个研究点目标入组 264 人开始时间: 待定最近更新: 2025年3月18日

试验速览

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•Japanese uterine fibroid patients
•Premenopausal female patient over 20 years old
•Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
•Larger than a certain standard
•No calcification
•Not receiving surgical treatment
•Patients with a normal menstrual cycle
•Patients diagnosed with menorrhagia

•Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
•Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
•Patients with undiagnosed abnormal genital bleeding

Proportion of subjects with a total PBAC score of less than 10

时间窗: Week 6 to 12 after beginning of study drug administration

Proportion of subjects with a total Pictorial Blood Assessment Chart (PBAC) score of less than 10

Proportion of subjects with a total PBAC score of less than 10(6 weeks before end of study drug administration)
Change from baseline in blood hemoglobin
Change rate from baseline in myoma volume
Change rate from baseline in uterine volume
Change from baseline in UFS-QOL score
Incidence of adverse events and adverse drug reactions
Changes and fluctuations from baseline in laboratory tests
Changes and fluctuations from baseline in vital signs
Changes and fluctuations from baseline in body weight
Changes and fluctuations from baseline in parameters of 12-lead ECG
Change rate from baseline in bone metabolic markers
Change rate from baseline in bone density

发起方