EUCTR2004-002076-42-HU进行中（未招募）1 期
Safety, hemostatic and metabolic effects and contraceptive efficacy of an oral monophasic contraceptive containing 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate (CG5025) used in two different regimens of intake - Not available
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,012
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
- •- Healthy, sexual active woman of child-bearing potential aged 18 - 40 years (non smoker) or 18 - 35 years (smoker) at admission
- •- Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator
- •- Wish for oral contraception for at least 392 days
- •- BMI = 30
- •- HEMOSTATIC/METABOLIC SUBGROUP:
- •- Healthy, non-smoking, sexual active woman of child-bearing potential aged 18 - 40 years at admission
- •- Wish for oral contraception for at least 392 days followed by approximately 2 months with a barrier method, e.g. condoms
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General criteria
- •- Pregnancy
- •- Breast feeding
- •- Evidence or history of alcohol, medication or drug dependency
- •- Severe psychiatric illness, epilepsy or suicide risk
- •- Any chronic disease (e.g. hepatic and/or renal) or diet that might affect drug absorption, metabolism or excretion
- •Study specific
- •- Planned surgery requiring withdrawal of an oral contraceptive during the anticipated time of participation in this study
- •- Cytologic evidence of intraepithelial neoplasia in a cervical smear (e.g. Pap smear grade III to V)
- •- Unexplained amenorrhea or genital bleeding
- •-Known polycystic ovary syndrome, anovulatory cycles, hysterectomy, bilateral oophorectomy
- •- Administration of any other hormonal contraceptives including patches and vaginal rings during the medication cycles
- •- Use of intra-uterine devices (IUD) with or without hormone impregnation during the medication cycles
- •- Use of implantable contraceptives during the medication cycles
- •- Use of injectable contraceptives within the preceding 6 months (date of injection) before admission and during the medication cycles
- •- Use of estrogen or progesterone containing medication during the medication cycles
- •- Regular concomitant use of a barrier method
- •- Migraine with focal neurological symptoms (migraine accompagnée)
- •- Need for concomitant treatment (longer than 5 days) with
- •medicines that increase gastrointestinal motility (e.g. metoclopramide) or impair absorption (e.g. activated charcoal)
- •active substances inducing microsomal enzymes in the liver such as rifampicin, rifabutin, barbiturates, anti-epileptics (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone, barbexaclone), griseofulvin, modafinil, protease inhibitors (e.g. ritonavir), or St. John’s Wort
- •antibiotics
- •- Hepatic diseases
- •- Circulation affecting and metabolic diseases
- •- Pancreatitis or history of such a condition, if associated with severe hypertriglyceridemia
- •- Tumors: presence, history or suspicion of any malignant or hormone-sensitive tumor
- •- Other diseases:
- •Porphyria (in particular acquired hepatic porphyria)
- •Otosclerosis deteriorating in previous pregnancies
- •Acute sensory disorders, e.g. visual or hearing disorders
- •Motor disorders, particularly paresis
- •Severe epigastric pain, enlargement of the liver, or symptoms of intraabdominal hemorrhage
- •Study specific for volunteers in hemostatic/metabolic subgroup
- •- Use of oral contraceptives, contraceptive vaginal rings, or contraceptive patches within 1 cycle before the pre-medication cycle
- •- Concomitant and prior use of intra-uterine devices (IUD) with or without hormone impregnation within 1 cycle before the pre-medication cycle
- •- Use of implantable contraceptives within the preceding 2 cycles before the pre-medication cycle
- •- Parturition, miscarriage, or abortion within the preceding 3 months before the baseline visit
- •- Concomitant use of anticoagulants, i.e. heparins and coumarins
- •- Concomitant medications affecting the lipoprotein and/or carbohydrate metabolism (e.g. systemic glucocorticoides, ß-blockers, thiazide diuretics, antilipemic agents)
- •- Concomitant diseases affecting the lipoprotein and/or carbohydrate metabolism (e.g. diabetes mellitus, hypothyroidism, cholestasis, nephrotic syndrome, renal insufficiency requiring hemodialysis)
- •- Fasting total cholesterol > 6.47 mmol/l (> 250 mg/dl) and/or triglycerides > upper limit of normal at baseline
- •- Concomitant use of platelet aggregation inhibitors and/or non-steroidal anti-i
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