Phase II Dose-Finding Study to Evaluate Efficacy and Safety of CDB-2914 in Patients with Uterine Myoma

ASKA Pharmaceutical Co., Ltd.0 个研究点目标入组 125 人开始时间: 2014年11月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients providing written informed consent
•-Premenopausal Japanese women between the ages of 20 and 50 years at the time consent is obtained
•-Patients with a menstrual cycle of 22 to 35 days
•-Patients with heavy bleeding for at least one day within the first 8 days of menstruation at screening who are diagnosed with menorrhagia
•-Patients with hemoglobin level from 6.0 g/dL to less than 11.5 g/dL at screening
•-Patients with one or more uterine myomas at least 3 cm in diameter and no uterine myomas more than 12 cm in diameter on pelvic MRI at screening
•-Patients whose uterus is no larger than at Week 16 of pregnancy at screening
•-Patients planning to undergo surgery (such as hysterectomy and myomectomy) at or after the end of the study treatment period
•-Patients who are able to practice appropriate birth control, including their partners, except for oral contraceptives, during the study period

•-Patients with a history of surgery potentially affecting uterine evaluation in the study, or patients with a history of endometrial curettage, embolization, or microwave endometrial ablation
•-Patients with prior, concurrent, or suspected cervical cancer, endometrial cancer, ovarian cancer, breast cancer, or endometrial hyperplasia
•-Patients with endometrial polyps greater than 2 cm
•-Patients with calcified myoma
•-Patients with one or more ovarian cysts 4 cm or greater
•-Patients with hemoglobinopathy or severe abnormal coagulation
•-Patients who are pregnant or lactating. Patients who have positive pregnancy test results at screening or who want to become pregnant during the study period
•-Patients with alcohol or substance addiction
•-Patients with allergies to investigational product ingredients, SPRMs, progestins, or GnRH derivatives
•-Patients with previous or concurrent osteoporosis
•-Patients with hepatic function abnormal at screening
•-Patients on SPRMs
•-Patients using IUDs

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