NL-OMON33654尚未招募3 期
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. - PGL4001 versus GnRH-agonist in uterine myomas
Preglem S.A0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent prior to any study related procedures.
- •Pre-menopausal woman between 18 and 50 years inclusive.
- •PBAC score >100 during day 1 to day 8 of menstruation preceding the baseline visit.
- •Myomatous uterus <= 16 weeks.
- •At least one uterine myoma of >= 3 cm diameter in size and no myoma larger than 10 cm diameter in size diagnosed by ultrasound.
- •Must 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.
- •Clinical breast examination without significant findings at the screening visit.
- •No clinically significant findings at 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
- •Non childbearing potential, tubal ligation sterilisation at least two months before study start.
- •BMI >= 18 and <= 40.
排除标准
- •Uterus surgery (except caesarean section or cervical conisation), endometrium ablation or uterine artery embolization.
- •History of or current uterine, cervical, ovarian or breast cancer.
- •Has a history of atypical hyperplasia or current endometrium hyperplasia (atypical or non-atypical) or adenocarcinoma or similar lesions in the screening biopsy or in a biopsy performed within the past 6 months.
- •Condition requiring immediate blood transfusion or a level of Hb <= 6 g/dL.
- •Known hemoglobinopathy (i.e. Sickel Cell anaemia and Thalassämia).
- •Known severe coagulation disorder.
- •Large uterine polyp (> 2cm).
- •One or more ovarian cysts >= 4cm in diameter diagnosed by US.
- •History of or current treatment for myoma with a SPRM or a GnRH-agonist.
- •Taking treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within the month before the screening visit. Or Acetylsalicylic acid and/or mefenamic acid, anticoagulants such as cumarins and /or antifibrinolytic drugs such as tranexamic: within one week before the screening visit, or Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively.
- •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, mefenamic acid, anticoagulants such as cumarins and/or antifibrynolytic drugs such as tranexamic acid
- •History of or known current osteoporosis.
- •Abnormal hepatic function at study entry (defined as AST, ALT, γGT, alkaline phosphatase or total bilirubin above 2 ULN).
- •Positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
- •Current (within twelve months) problem with alcohol or drug abuse.
- •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •The subject 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. This does include the use of agents known to induce or inhibit the hepatic cytochrome CYP3A4.
- •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),
- •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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