A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PregLem SA
- 入组人数
- 451
- 试验地点
- 48
- 主要终点
- Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
研究概览
简要总结
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
详细描述
The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be a pre-menopausal woman between 18 and 50 years inclusive.
- •Have a Body Mass Index (BMI) ≥ 18 and ≤
- •Have FSH levels ≤ 20 mIU/mL
- •Have excessive uterine bleeding due to myoma.
- •Have regular menstrual cycles
- •Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
- •If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
排除标准
- •Has a history of or current uterine, cervical, ovarian or breast cancer.
- •Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
- •Has a known severe coagulation disorder.
- •Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
- •Has abnormal hepatic function at study entry.
- •Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
- •Has a current (within twelve months) problem with alcohol or drug abuse.
- •Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
研究组 & 干预措施
Ulipristal acetate (PGL4001) 5mg
All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
干预措施: PGL4001 5 mg (Drug)
Ulipristal acetate (PGL4001) 10mg
All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
干预措施: PGL4001 10 mg (Drug)
结局指标
主要结局
Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
时间窗: 18 months study duration per subject (4 3-month intermittent treatment courses)
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.
次要结局
- Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4(After 18 months)
- Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses(After 18 months)
- Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)(After 18 months)
- Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids(After 18 months)
- Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)(After 18 months)
- Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)(18 months)