EUCTR2012-000041-12-NL进行中（未招募）不适用
Characterisation of ovulation inhibition and effects on metabolic parameters and haemostatic system of multiple administrations of a fixed-dose combination product containing 0.02 mg ethinylestradiol and 2 mg dienogest (24+4) in a multiple administration, comparative parallel-group trial vs. a marketed product containing 0.02 mg ethinylestradiol and 0.10 mg levonorgestrel with healthy females of childbearing potential - Ovulation inhibition study with ethinylestradiol 0.02 mg/ dienogest 2 mg
Zentiva k.s. Prague0 个研究点开始时间: 2012年3月15日最近更新:
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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
- •2.age: 18 – 35 years inclusive; questioned at screening examination
- •3.body-mass index (BMI): =30.0 kg/m²; determined at screening examination
- •4.good state of health
- •5.both ovaries visible upon transvaginal ultrasonography; observed at screening examination
- •6.ovulation observed by TVUS on or before day 27 (±1) of the pre-treatment cycle
- •7.progesterone blood concentration =16 nmol/L within 5 days after ovulation has been observed during pre-treatment cycle
- •8.non-smoker, ex-smoker for at least 6 months or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged =30 years; questioned at screening examination
- •9.written informed consent, after having been informed about benefits and potential risks of the clinical trial
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.existing diseases or pathological findings of uterus and/or ovaries which might interfere with the efficacy, safety or tolerability of the IMPs
- •2.existing cardiac or haematological diseases or related pathological findings which might interfere with the efficacy, safety or tolerability of the IMPs
- •3.existing hepatic and/or renal diseases or related pathological findings which might interfere with the efficacy, safety or tolerability of the IMPs
- •4.existing gastrointestinal diseases or related pathological findings which might interfere with the absorption, efficacy, safety or tolerability of the IMPs
- •5.history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •6.known allergic reactions or intolerances to the active ingredients used or to constituents of the pharmaceutical preparations
- •7.subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- •8.severe and/or uncontrolled hypertension
- •9.systolic blood pressure >140mmHg
- •10.diastolic blood pressure >90mmHg
- •11.heart rate >100bpm
- •12.laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- •13.presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or prodromal conditions (e.g. angina pectoris, transient ischaemic attack)), cerebrovascular insult, hereditary or acquired predisposition for venous or arterial thrombosis
- •14.anamnestic signs for increased risk of thrombotic events in family history
- •15.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)
- •16.presence or history of tumours (benign or malignant) of liver and pituitary
- •17.known or suspected sex-hormone influenced malignancies, e.g. of genital organs or breasts
- •18.abnormal PAP smear (>PAP II) at screening examination or documentation of abnormal smear performed within 2 years prior to screening examination
- •19.severe dyslipoproteinaemia
- •20.Diabetes mellitus
- •21.unclarified vaginal bleeding
- •22.amenorrhea with unkown cause
- •23.history or signs of migraine with focal neurological symptoms
- •24.any acute or chronic disease, disorder and/or abnormality which may interfere with the aims of the clinical trial
- •25.history of or current drug or alcohol dependence
- •26.regular intake of alcoholic beverages of >2 units per day
- •27.blood donation or other blood loss of more than 400ml within the last 2 months prior to individual start of pre-treatment cycle of the subject
- •28.use of any investigational drug during the last 2 months prior to individual start of pre-treatment cycle of the subject
- •29.repeated intake of any systemically available medication during the last 2 months prior to start of pre-treatment cycle which might interfere with absorption, pharmacodynamics or safety of the IMPs
- •30.repeated intake of medication during the last 2 months prior to start of the pre-treatment cycle which is known to interfere with gastrointestinal and/or hepatic enzymes (e.g. phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, nevirapin, griseofulvin, ketoconazole, herbal remedies containing Hyperi
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