A phase 3, randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of AKP-022 administered for 24 weeks in patients with uterine fibroids (LUNA1)

ASKA Pharmaceutical Co., Ltd.0 个研究点目标入组 75 人开始时间: 2025年2月26日最近更新: 2025年4月24日

试验速览

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•Japanese premenopausal female patients who are aged 18 years or older
•Patients who had consecutive days of menstrual bleeding
•Patients with at least 1 measurable fibroid on transvaginal ultrasound, excluding calcified fibroids
•Patients with a diagnosis of menorrhagia
•Patients who are capable of using appropriate contraception during the study period

•Patients who have had a hysterectomy or bilateral oophorectomy
•Patients with pathologic findings other than uterine fibroid that could either cause or contribute to menorrhagia, or any other clinically significant gynecologic disorder
•Patients with a current history of thyroid dysfunction with irregular menstruation, or with a potential for irregular menstruation due to thyroid dysfunction
•Patients with undiagnosed abnormal vaginal bleeding
•Patients with marked metrorrhagia or anovulatory bleeding
•Patients with current or previous blood disorders (e.g., thalassemia, sickle cell anemia, folic-acid deficiency, and coagulopathy), excluding iron-deficiency anemia or latent iron-deficiency anemia
•Patients with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
•Patients with current or previous osteoporosis, osteopenia, or other metabolic bone diseases

Proportion of participants with a total PBAC score of < 10

时间窗: Week 18 to Week 24 of study treatment

Proportion of participants with a total Pictorial Blood Assessment Chart (PBAC) score of < 10

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