EUCTR2010-018999-25-BE进行中（未招募）1 期
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. - PEARL III: PGL4001 Efficacy Assessment in Reduction of symptoms due to uterine Leiomyomata
PregLem S.A.0 个研究点目标入组 200 人开始时间: 2010年6月15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 study related procedures.
- •2.Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
- •3.Subject with a Body Mass Index =18 and =40.
- •4.Subject with hormonal levels FSH = 20 mIU/mL at screening.
- •5.Subject with regular menstrual cycles =22 and =35 days.
- •6.Subject with myomatous uterus size < 16 weeks.
- •7.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.
- •8.Subject complained of strong uterine bleeding (subjective assessment).
- •9.Subject is eligible for hysterectomy or myomectomy.
- •10.Subject has no significant findings at clinical breast examination at the screening visit.
- •11.Females of childbearing potential have to practice a non-hormonal method of contraception until completion of visit 7 among one of the following:
- •-Sexual abstinence
- •-Diaphragms
- •-Condom or partner with a vasectomy with confirmed azoospermia or performed at least 6 months prior to the study.
- •12.Females of non childbearing potential, defined as women with tubal ligation sterilisation at least two months before the screening visit (visit 1)
- •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
- •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 history of uterus surgery that would interfere with the study, including endometrial ablation or uterine artery embolization.
- •2.Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- •3.Subject has a significant finding on Papanikolaou test (PAP) smear within the past 12 months.
- •4.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.
- •5.Subject has a large uterine polyp (> 2cm).
- •6.Subject has calcified myomas and/or calcified uterus.
- •7.Subject has a known severe coagulation disorder.
- •8.Subject has one or more ovarian cysts = 4cm diagnosed by ultrasound.
- •9.Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
- •10.Subject has been taking:
- •-Treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within one month before the screening visit.
- •-Acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid: within one week before the screening visit,
- •-Treatments with an PRM or progesterone antagonist within one month before the screening visit
- •-Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one or three months before the screening visit, respectively.
- •-GnRH agonist within 3 months before the screening visit.
- •-Treatments which contain PgP substrate (digoxin, fexofenadine), two weeks prior to visit 2.
- •-Treatments which contain moderate or potent inhibitors or inducers of CYP3A4, two weeks prior to visit 2.
- •11.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), GnRH-Agonists, acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid, treatments which contain PgP substrate (digoxin, fexofenadine), treatments which contain moderate or potent inhibitors or inducers of CYP3A4.
- •12.Subject has abnormal hepatic function at study entry (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). In case of an isolated increase of GGT, the subject may be enrolled if the re-test is within the allowed limits.
- •13.Subject has lactose or galactose intolerance (i.e. lapp lactase deficiency or glucose-galactose malabsorption).
- •14.Subject is at high risk of thromboembolic disease. This precaution is necessary because subjects may be randomised to norethisterone acetate.
- •15.Subject has a positive pregnancy test at baseline, is nursing or planning a pregnancy during the course of the study.
- •16.Subject has a current (within twelve months prior to screening visit) problem with alcohol or drug abuse.
- •17.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.
- •18.Subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safe
研究者
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