EUCTR2016-000115-32-DE进行中（未招募）1 期
Characterization of ovulation inhibition of a new vaginal delivery system (EVE 112, Evestra/Germany) containing etonogestrel and ethinylestradiol – an open label, single centre, comparative, parallel-group study in healthy females of childbearing potential - Ovulation inhibition study with etonogestrel and ethinylestradiol
Evestra GmbH0 个研究点开始时间: 2016年1月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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.Sex: female
- •2.Age: = 18 years and = 35 years
- •3.Body-mass index (BMI): = 18.5 kg/m² and = 30.0 kg/m²
- •4.Good state of health
- •5.Non-smoker, ex-smoker for at least 3 months or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged =30 years only; questioned at screening examination
- •6.Both ovaries visible upon transvaginal ultrasonography; observed at screening examination
- •7.Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in 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 88
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Existing cardiac and/or haematological diseases or pathological findings which might interfere with the efficacy, safety and/or tolerability of the active ingredients
- •2.Existing hepatic and/or renal diseases or pathological findings which might interfere with the efficacy, the safety and/or tolerability of the active ingredients
- •3.Existing diseases or pathological findings of genital organs which might interfere with efficacy, safety and/or tolerability of the IMPs
- •4.History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •5.Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
- •6.Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- •7.Systolic blood pressure > 140 mmHg
- •8.Diastolic blood pressure > 90 mmHg
- •9.Pulse rate < 50 bpm or > 90 bpm
- •10.Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- •11.Positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if positive to be verified by test for HBc-IgM) or anti-HCV-test
- •12.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 accident, inborn or acquired predisposition for venous or arterial thrombosis
- •13.Anamnestic hints for increased risk of thrombosis events in family history
- •14.Known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance, antithrombin-III-deficiency, protein-C or –S-deficiency
- •15.Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)).
- •16.Known medical factors coming along with an increased risk of venous and/or arterial thromboembolism as e.g. systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease, and dyslipoproteinaemia
- •17.Presence or history of liver tumours (benign or malignant) or known or suspected sex-hormone influenced malignancies of the genital organs or breasts
- •18.Severe lipopathy
- •19.Diabetes mellitus
- •20.Unclarified vaginal bleeding
- •21.Existing cervicitis, vaginitis or bleeding cervical erosions
- •22.Diagnosis of a cervical smear: Bethesda classification AGC, LISL or HSIL (corresponds to Papanicolaou class III or higher)
- •23.Prolapse of uterine cervix, cystocele and/or rectocele
- •24.Severe or chronic constipation
- •25.History of migraine with focal neurological symptoms
- •26.Acute or chronic diseases which may interfere with the aims of the clinical trial
- •27.History of or current drug or alcohol dependence
- •28.Regular intake of alcoholic food or beverages of = 20 g pure alcohol per day
- •29.Blood donation or other blood loss of more than 400 mL within the last 2 months prior to individual start of pre-treatment cycle of the subject
- •30.Participation in a clinical trial during the last 2 months prior to individual start of pre-treatment cycle of the subject
- •31.Regular treatment with any systemically available medication during the last 2 weeks prior to start of pre-treatment cycle which might interfere with pharmacodynamics or safety of the IM
研究者
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