EUCTR2015-005124-25-BG进行中（未招募）1 期
Open-label, multi-center, randomized parallel group study to assess the pharmacokinetic (PK) profile of Zoreline 3.6 mg goserelin subcutaneous implant (test product, Novalon S.A.) and of Zoladex® 3.6 mg goserelin subcutaneous implant (reference product, AstraZeneca UK Limited) in women with confirmed endometriosis.
ovalon S.A.0 个研究点目标入组 68 人开始时间: 2016年5月13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
- 68
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
- •1. Women aged between 18 and 45 years (inclusive), who are not menopausal.
- •2. Clinical diagnosis of endometriosis, within the last 5 years indicated for treatment with hormone therapy as judged by the investigator.
- •Note: As per clinical guidelines: Clinical diagnosis is be based on clinical symptoms of endometriosis (such as chronic pelvic pain, dyspareunia, cyclic intestinal pain (bloating/diarrhoea/constipation), uterine cramping in young females, severe dysmenorrhea, dyspareunia, ovulation pain, cyclical/menstrual symptoms with or without abnormal bleeding, infertility, chronic fatigue) confirmed by laparoscopy (with or without histology) and/or transvaginal/rectal ultrasound (bladder, ovarian or rectum locations) and/or enema studies (for deeply infiltrating endometriosis).
- •3. Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs.
- •4. Willing to give informed consent in writing.
- •5. Willing to use non-hormonal anti-conception from screening visit till the end of treatment (Day 29 of Period 2).
- •6. Willing and able to attend the scheduled study visits and to comply with the study procedures.
- •7. Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- •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 68
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous or current hormonal treatment for endometriosis: including usage of GnRH receptor agonists or GnRH receptor antagonists within 6 months prior to the screening visit.
- •2. Use of treatments that interfere with estradiol plasma level within one week (or 5 half-lives, whichever is longer) before drug administration.
- •3. Endometriosis surgery scheduled in the period between screening and end of study.
- •4. Alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) or aspartate transaminase (AST) / serum glutamic oxaloacetic transaminase (SGOT) levels = 2x upper limit of normal (ULN) or GGT = 2.5 x upper limit of normal.
- •5. Evidence (including clinically significant abnormal bilirubin and/or albumin values) or history for chronic hepatic disease. Gilbert’s disease however is allowed.
- •6. Moderate or severe chronic kidney disease with an estimated glomerular filtration rate (eGFR), calculated by using the modification of diet in renal disease (MDRD) equation, < 60 mL/min/1,73m2.
- •7. Use of implanted long-acting progestin treatments like nexplanon or implanon at less than 1 month before the screening visit.
- •8. Receipt of an investigational drug within the last 28 days before the Screening visit (or 5 times the half-life of the drug, whichever is longer), if considered by the investigator to possibly influencing the outcome of this trial.
- •9. An unstable medical condition or chronic disease (including history of neurological [including cognitive and untreated depression], cardiovascular [including uncontrolled hypertension], gastrointestinal, pulmonary, bone, metabolic or endocrine disease), or malignancy that could confound interpretation of the study at investigator’s discretion.
- •10. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study drug.
- •11. History or presence of any malignancy other than treated squamous cell/basal cell carcinoma within the last 5 years.
- •12. Loss in bone mass that could affect the patient's health.
- •13. Prolonged QTc interval defined as mean QTcF > 450 ms at Screening or on Day 1 of Period 1 as measured by triplicate ECG.
- •Note: If the mean value of the QTcF interval from the three measurements is above 450 ms, another triplicate ECG should
- •be recorded once.
- •14. Family history for prolonged QT interval including history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative.
- •15. Patients with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within 6 months before Visit 1 ( Screening visit ).
- •16. History of hospitalization within 12 months before Visit 1 (Screening visit) caused by heart failure or a diagnosis of heart failure higher than New York Heart Association Class II.
- •17. Patient with decompensated diabetes mellitus.
- •18. Other abnormal laboratory results, which according to the investigator would affect the patient's health or the outcome of the trial.
- •19. Pregnancy (or willingness to become pregnant during the study) or breast-feeding.
- •20. Intellectual incapacity or inability to comprehend, precluding adequate understanding or co-operation.
- •21. Any contraindications for goserelin administration.
研究者
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