EUCTR2010-019497-32-BE进行中（未招募）1 期
A Phase III, multicentre, clinical study investigating the efficacy and safety of three successive periods of 3-month open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and a drug-free period until return of menses, in subjects with myomas and heavy uterine bleeding. - PEARL III extension
PregLem S.A.0 个研究点目标入组 200 人开始时间: 2010年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •To be eligible for inclusion into this study, the subjects must fulfil all of the following criteria:
- •1. Provision of written informed consent prior to any PGL09-027 study related procedures.
- •2. Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.
- •3. Subject has no contraindication to enter the extension study, based on the responsible investigator’s judgment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- •1. Subject has a large uterine polyp (> 2cm).
- •2. Subject has one or more ovarian cysts = 4cm diagnosed by ultrasound at visit 6 of PGL09-026.
- •3. Subject is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), hormonal contraceptives, systemic glucocorticoids (oral and injectable), acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins, antifibrynolytic drugs such as tranexamic acid, treatments containing PgP substrates (digoxin, fexofenadine), and/or treatments containing moderate or potent inhibitors or inducers of CYP3A4.
- •4. Subject has abnormal hepatic function at re-test (defined as aspartate transaminase [AST], alanine transaminase [ALT], gamma glutamyl transferase [GGT], hepatic alkaline phosphatase, or total bilirubin above twice the upper limit of normal). A re-test will be performed if hepatic function test values are above twice the upper limit of normal at visit 5 of PGL09-026 study. If the second test result is still above twice the upper limit of normal, the subject cannot be included. In case of isolated GGT, the subject may be enrolled if the re-test is within the allowed limits.
- •5. Subject has a lactose or galactose intolerance (i.e. lapp lactase deficiency or glucose-galactose malabsorption)
- •6. Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
- •7. Subject has a current problem with alcohol or drug abuse.
- •8. Subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •9. Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or interfere with study evaluations.
研究者
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