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临床试验/jRCT2031240570
jRCT2031240570招募中不适用

A phase 3, multicenter, open-label, uncontrolled, long-term treatment study to evaluate the safety and efficacy of AKP-022 administered for 52 weeks in patients with uterine fibroids (LUNA2)

ASKA Pharmaceutical Co., Ltd.0 个研究点目标入组 350 人开始时间: 2025年2月7日最近更新:
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试验速览

阶段
不适用
状态
招募中
入组人数
350
主要终点
Percent change in BMD from baseline
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit（—）
性别
Female

入选标准

  • •Japanese premenopausal female patients who are aged 18 years or older
  • •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

排除标准

  • •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

结局指标

主要结局

Percent change in BMD from baseline

时间窗: Week 52 of study treatment

Percent change in Bone Mineral Density (BMD) from baseline

Incidence rate of endometrial hyperplasia

时间窗: up to Week 52 of study treatment

Incidence rate of endometrial hyperplasia

次要结局

未报告次要终点

研究者

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