A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PregLem SA
- 入组人数
- 209
- 试验地点
- 20
- 主要终点
- Efficacy endpoints
研究概览
简要总结
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
详细描述
PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
- •Subject with a Body Mass Index ≥18 and ≤
- •Subject with myomatous uterus size < 16 weeks.
- •Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
- •Subject complained of strong uterine bleeding.
- •Subject is eligible for hysterectomy or myomectomy.
- •Females of childbearing potential have to practice a non-hormonal method of contraception.
排除标准
- •Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- •Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
- •Subject has a known severe coagulation disorder.
- •Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
- •Subject has abnormal hepatic function at study entry.
研究组 & 干预措施
A
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
干预措施: PGL4001, placebo (Drug)
B
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
干预措施: PGL4001, progestin (Drug)
结局指标
主要结局
Efficacy endpoints
时间窗: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.
Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).
Number and proportion of subjects experiencing open label treatment-emergent adverse events
时间窗: From baseline to end of PGL4001 treatment (3months treatment)
次要结局
未报告次要终点