EUCTR2006-001546-14-NL进行中（未招募）1 期
A randomized, open-label, comparative trial to evaluate the effects on ovarian function of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drospirenone (DRSP) and 30 µg ethinyl estradiol (EE).
V Organon0 个研究点目标入组 48 人开始时间: 2006年8月3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
- 入组人数
- 48
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
- •Women willing to use a combined oral contraceptive for 6 cycles;
- •At least 18 but not older than 35 years of age at the time of screening;
- •Body mass index =17 and =35;
- •Good physical and mental health;
- •Willing to use condoms as the sole contraceptive method during the screening cycle and during one
- •post-treatment cycle.
- •Willing to give informed consent in writing.
- •Additional inclusion criterion for entering the treatment phase
- •Confirmed ovulation in the screening cycle on or before Cycle Day 27;
- •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
- •Contraindications for contraceptive steroids:
- •- Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis,
- •pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;
- •- Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris);
- •- History of migraine with focal neurological symptoms;
- •- Diabetes mellitus with vascular involvement;
- •- The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the
- •(sub)-investigator).
- •e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age); obesity (body mass index over 30 kg/m2); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery, any surgery to the legs, or major trauma (in these situations it is advisable to discontinue the COC use and not to resume until two weeks after full remobilization); systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis); sickle cell disease.
- •- Severe dyslipoproteinemia
- •- Severe hypertension
- •- Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance,
- •antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia
- •and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
- •- Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
- •- Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
- •- Presence or history of liver tumors (benign or malignant);
- •- Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);
- •- Undiagnosed vaginal bleeding;
- •- Known or suspected pregnancy;
- •- Hypersensitivity to the active substances or to any of the excipients of the investigational product.
- •In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications
- •related to the antimineralocorticoid activity of drospirenone (conditions that predipose to hyperkalemia):
- •- Renal insufficiency;
- •- Hepatic dysfunction;
- •- Adrenal insufficiency.
- •Breastfeeding;
- •Present use or use within 2 months prior to the start of the trial medication of the following drugs:
- •phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate,
- •rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post
- •treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John’s Wort);
- •Administration of any other investigational drugs and/or participation in another clinical trial
- •within 2 months prior to the start of the trial medication or during the trial period.
- •An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), Squamous Intraepithelial
- •Lesion (SIL), carcinoma in situ, invasive carcinoma) at screening, or documentation of an abnormal
- •smear performed within 6 months before screening;
- •Clinically relevant abnormal laboratory result at screening as judged by the investigator.
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