EUCTR2008-001805-40-IT进行中（未招募）不适用
A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas. - PEARL II
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PREGLEM SA
- 入组人数
- 300
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
- •In order to be included, subject must:
- •Provide written informed consent prior to any study related procedures.
- •Be a pre-menopausal woman between 18 and 50 years inclusive.
- •Have a PBAC score >100 during day 1 to day 8 of menstruation preceding the baseline visit.
- •Have a myomatous uterus volume ≤ 16 weeks.
- •Have at least one uterine myoma of ≥ 3 cm diameter in size and no myoma larger than 10 cm diameter in size diagnosed by ultrasound.
- •Be eligible for one of these surgical procedures: i.e. hysterectomy, myomectomy, uterine artery embolization or endometrial ablation within 13 weeks and up to 14 weeks from baseline study visit.
- •Have a clinical breast examination without significant findings at the screening visit.
- •Have no clinically significant findings at Papanikolaou test (PAP) smear, performed within the past 12 months or at the screening visit.
- •If of childbearing potential the subject must be practicing a non-hormonal method of contraception as listed below:
- •-Sexual abstinence
- •-Diaphragms
- •-Condom or partner with a vasectomy performed at least 6 months prior to the study and confirmed azoospermia.
- •If of non childbearing potential, the subject must have had a tubal ligation sterilisation at least two months before study start.
- •Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
- •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
- •Subject will be excluded from participation; if she:
- •Has a history of uterus surgery (except caesarean section or cervical conisation), endometrial ablation or uterine artery embolization.
- •Has a history of or current uterine, cervical, ovarian or breast cancer.
- •Has a history of or current endometrium atypical hyperplasia or adenocarcinoma or similar lesions in the screening biopsy or in a biopsy performed within the past 6 months.
- •Has a condition requiring immediate blood transfusion or a level of Hb ≤ 6 g/dL.
- •Has a known hemoglobinopathy (i.e. Sickel Cell anaemia and Thalassämia).
- •Has a known severe coagulation disorder.
- •Has a large uterine polyp (> 2cm).
- •Has one or more ovarian cysts ≥ 4cm in diameter diagnosed by Ultrasound (US).
- •Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
- •Has been taking:
- •-Treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within the month before the screening visit,
- •-Acetylsalicylic acid and/or mefenamic acid: within one week before the screening visit,
- •-Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively.
- •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), oral contraceptives, systemic glucocorticoids (oral and injectable), acetylsalicylic acid and/or mefenamic acid.
- •Has a history of or known current osteoporosis.
- •Has abnormal hepatic function at study entry (defined as Aspartate transaminase (AST), Alanine transaminase (ALT), Gamma Glutamine Transferase (γGT), alkaline phosphatase or total bilirubin above 2 Upper Limit of Normal range (ULN)).
- •Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
- •Has a current (within twelve months) problem with alcohol or drug abuse.
- •Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •Has abnormal baseline findings, any other medical condition(s) or psychiatric condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject?s safety or interfere with study evaluations.
- •Has an allergy to GnRH agonist, SPRMs or progestins or any of the ingredients of the study drug tablet (see list of ingredients in the investigator?s brochure),
- •Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
研究者
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