EUCTR2008-002142-38-GB进行中（未招募）不适用
A phase I, single center, open-label parallel group trial to compare the pharmacokinetics of NOMAC between healthy female adolescents (aged 14-17 years) and healthy female adults (aged 18-50 years) after single dose administration of NOMAC-E2 tablets
V Organon0 个研究点开始时间: 2008年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Female subjects between 18 and 50 years of age (extremes included) which have a normal menstrual cycle as judged by the investigator or female subjects between 14 and 17 years of age (extremes included) after menarche, which have a history of at least six months of normal menstrual cycles, which is in accordance with the age of the subjects, as judged by the investigator.
- •2. A body mass index (BMI) between 17 and 29 kg/m2 (extremes included).
- •3. Able and willing to sign the Informed Consent Form prior to screening evaluations. For the subjects between 12 and 17 years of age a parental informed consent is needed in addition.
- •4. (History of) good physical and mental health as determined by history taking, physical and laboratory examinations, ECG and vital signs recordings as judged by the investigator and taken into account the age of the subjects.
- •5. Able and willing to stop their own hormonal contraceptive, if used, one month before drug administration.
- •6. Able and willing to use non-hormonal contraceptives during the trial from screening up to and including follow-up. E.g. condoms with spermicide, diaphragm with spermicide, non-hormonal intra-uterine device (IUD), a vasectomized (> 6 months) partner or previous tubal ligation.
- •7. Subject smokes less than 5 cigarettes or equivalent per day and is capable of not smoking from 48 hours prior to drug administration until the last pharmacokinetic blood sample has been taken.
- •8. Able to refrain from all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate, red bull and other energy drinks) and alcohol from 48 hours prior to drug administration until the last pharmacokinetic blood sample has been taken.
- •9. Able to refrain from all use of grapefruit containing products from 7 days prior to drug administration until the last pharmacokinetic blood sample has been withdrawn.
- •Are the trial subjects under 18? yes
- •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
- •1. Clinically relevant history or presence of any medical disorder, potentially interfering with this pharmacokinetic trial.
- •2. Contraindications for the use of contraceptive steroids.
- •a. Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;
- •b. Presence or history of prodromi of a thrombosis (e.g. transient ischemic attack, angina pectoris);
- •c. History of migraine with focal neurological symptoms;
- •d. Diabetes mellitus with vascular involvement;
- •e. The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the(sub)-investigator). e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery or any surgery to the legs or major trauma of which the remobilization had not fully resumed within 2 weeks prior to screening. In these situations it is advisable to discontinue the COC use and not to resume until two weeks after full remobilization; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis); sickle cell disease;
- •f. Severe dyslipoproteinaemia
- •g. Severe hypertension
- •h. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
- •i. Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
- •j. Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
- •k. Presence or history of liver tumors (benign or malignant);
- •l. Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);
- •m. Undiagnosed vaginal bleeding;
- •3. History of sensitivity/idiosyncrasy to NOMAC-E2 or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past.
- •4. Use of any drug or substance that is known to induce drug-metabolizing enzymes within two months prior to drug administration.
- •5. Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration before screening.
- •6. Use of any drug or substance within one week prior to drug administration, except for paracetamol or topical medication without systemic exposure.
- •7. Known or suspected pregnancy.
- •8. Breastfeeding or within 2 months after stopping breastfeeding prior to drug administration.
- •9. Before spontaneous menstruation has occurred following a delivery or abortion.
- •10. History of or current abuse of drugs or alcohol or solvents.
- •11. Positive drug or alcohol screen at screening or admission (day -1).
- •12. Participation in an investigational drug study within 90 days prior to drug administration.
- •13. Donation of blood within 90 days prior to drug administration.
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