EUCTR2004-001614-13-DE进行中（未招募）不适用
A single-center, open-label, controlled, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) as compared to a sequential oral contraceptive containing ethinylestradiol and levonorgestrel (SH D00264A) on plasma lipids, hemostatic variables, and carbohydrate metabolism in 60 healthy female volunteers aged 18-50 years over 7 treatment cycles - Metabolism study vs Triquilar 21+7
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 60
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 female volunteers requiring contraception
- •- Age between 18 and 50 years (inclusive) at Visit 1, smokers not older than 30
- •years and with a daily cigarette consumption not exceeding 10
- •- Non-suspicious cervical smear taken at Visit 1 or within the last 6 months before
- •- Signed and dated informed consent.
- •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
- •- Pregnancy, lactation
- •- Occurrence of less than 3 menstrual cycles before Visit 1 following delivery,
- •abortion, or lactation
- •- Amenorrhoea
- •- Known hypersensitivity to any ingredient of the study drugs
- •- Any known diseases or conditions that compromise the function of the body
- •systems and could result in altered absorption, excessive accumulation, impaired
- •metabolism, or altered excretion of the study medication
- •- Any known severe systemic disease that might interfere with the conduct of the
- •study or the interpretation of the results
- •- Known thyroid disorders
- •- Clinically significant depression (current or in the last year)
- •- Any known abnormal clinically significant findings which, according to the
- •assessment of the Investigator, may worsen under hormonal treatment
- •- Laboratory values outside the inclusion range at Screening
- •- Participation in another clinical study or administration of an investigational drug
- •within 1 month prior to Visit 1
- •- Operations scheduled in the study period
- •Known liver diseases:
- •- Previous, acute and chronic progressive liver diseases, e.g., disturbances of
- •bilirubin excretion in the bile (Dubin-Johnson and Rotor syndromes), disturbances of
- •bile secretion, disturbances of bile flow (cholestasis, also a history thereof,
- •idiopathic icterus or pruritus during a former pregnancy or estrogen-progestin
- •- Between the subsidence of a viral hepatitis (normalization of liver parameters) and
- •the beginning of the study there must be an interval of at least 6 months
- •- Previous or current liver tumors.
- •Known vascular and metabolic diseases:
- •- Existing or previous venous thromboembolic diseases (deep vein thrombosis,
- •pulmonary embolism), existing or previous arterial thromboembolic diseases
- •(myocardial infarction, stroke), as well as any condition increasing the disposition to
- •any of the above, e.g., coagulation disorders with tendency to blood clot formation,
- •hereditary anti-thrombin III deficiency, protein-C and/or protein-S deficiency, any
- •venous thromboembolic event occurred in a close relative (parent or sibling) at a
- •young age ( dysfunction (NYHA I-IV), strong predisposition to varicosis veins, previous phlebitis
- •- Known arterial hypertension (persistent systolic blood pressure > 140 mmHg
- •and/or diastolic blood pressure > 90 mmHg)
- •- Known diabetes mellitus, impaired glucose tolerance
- •- Known disturbances of lipid metabolism.
- •Known sickle-cell anemia
- •- Known or suspected malignant or premalignant disease, in particular steroid-
- •hormone dependent malignant or premalignant diseases (e.g., endometrial cancer,
- •breast cancer), also a history thereof
- •Known other diseases:
- •- Pemphigoid gestationis during a previous pregnancy, middle-ear deafness
- •(otosclerosis), endometrial hyperplasia, genital bleeding of unknown origin,
- •migraine with neurological symptoms (complicated migraine), manifest kidney
- •disease with impaired renal function, porphyria
- •Known alcohol, drug, or medicine abuse (e.g., laxatives)
- •Prohibited concomitant medication:
- •- Additional sex steroids, hydantoins (e.g., phenytoin), barbiturates (e.g.,
- 另有 4 项未显示
研究者
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