EUCTR2017-004664-36-DE进行中（未招募）1 期
Characterization of ovulation inhibition of a new vaginal delivery system containing trimegestone - an open-label, single-centre study in healthy females of childbearing potential - Ovulation inhibition study with trimegestone
Evestra GmbH0 个研究点目标入组 100 人开始时间: 2018年4月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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. 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
- •2. sex: female
- •3. age: 18 years to 38 years inclusive
- •4. body-mass index (BMI): >= 18 kg/m² and = 30.0 kg/m²
- •5. good state of health
- •6. non-smoker or ex-smoker for at least 3 months aged >30 years or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged = 30 years only; questioned at screening examination
- •7. both ovaries visible upon transvaginal ultrasonography; observed at screening examination
- •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 100
- •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 safety or tolerability of the active ingredient
- •2.existing hepatic and/or renal diseases (e.g. severe renal insufficiency or acute renal failure) or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- •3. existing diseases or pathological findings of genital organs, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- •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 < 80 or >= 140 mmHg
- •8. diastolic blood pressure < 50 or >= 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. ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history)
- •12. 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
- •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 accident, inborn or acquired predisposition for venous or arterial thrombosis
- •14. anamnestic hints for increased risk of thrombosis events in family history
- •15. known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance, antithrombin-III-deficiency, protein-C or -S-deficiency
- •16. known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
- •17. 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
- •18. Presence or history of liver tumours (benign or malignant) or known or suspected malignancies of the genital organs or breasts (mammae), regardless of the hormone status
- •19. Presence or history of leiomyoma, endometriosis, or endometrial hyperplasia
- •20. Known severe lipopathy
- •21. Fibrocystic mastopathy
- •22. Diabetes mellitus
- •23. Hereditary angioedema
- •24. Unclarified vaginal bleeding
- •25. Existing cervicitis, vaginitis or bleeding cervical erosions at day of randomisation
- •26. Diagnosis of latest PAP smear: findings classified in a group higher than PAP I
- •27. Prolapse of uterine cervix, cystocele and/or rectocele
- •28. History of severe or chronic constipation
- •29. Presence or history of migraine as defined by criteria of International Headache Society
- •30. Acute or chronic diseases, which may interfere with the aims of the clinical trial
- •31. history of or current drug or alcohol dependence
- •32. regular intake of alcoholic food or beverages of > 20 units alcohol
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