EUCTR2007-005476-14-NL进行中（未招募）不适用
A feasibility study into the contraceptive effect of estetrol alone or combined with either progesterone or desogestel by daily oral administration to healthy female volunteers for 28 days - Ovulation inhibition of estetrol
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •At least 18 years and not older than 40 years of age
- •Willing to use a barrier method of contraception during the wash-out cycle, the pre-treatment cycle, the period of study drug administration, the period of lynestrenol intake (if applicable), and 14 days thereafter or until the follow-up visit if this 14-days period ends before the follow-up visit.
- •Women who ovulate in the pre-treatment cycle before or on day 24 (±1) after start of their menses, who have a subsequent P concentration of above 16 nmol/l and whose next menstruation does not start within 7 days after ovulation
- •Body Mass Index between 18 and 30 kg/m2
- •Good physical and mental health
- •Both ovaries visible upon ultrasonography
- •Willing to give informed consent in writing
- •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
- •Clinically significant abnormal results of routine hematology, serum biochemistry, urinanalysis, and/or ECG in the opinion of the Investigator at screening.
- •Known or suspected pregnancy
- •Known or suspected breast cancer or a history of breast cancer
- •Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound (non-physiological ovarian mass or significant uterine pathology).
- •A cervical smear with clinically relevant abnormal cytology within one year before study start.
- •Previous use of depot progestogen preparations in the last 6 months.
- •Contraindications for contraceptive steroids:
- •-a history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
- •-a history of, or existing conditions predisposing to, or being prodromi of, a thrombosis
- •-a known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, and APC resistance)
- •-heterozygous for a mutation in coagulation factor II and/or positive for factor V Leiden
- •-the presence of a severe or more than one risk factor for vascular disease (e.g. dyslipoproteinaemia; diabetes mellitus; hyperhomocysteinaemia; systemic lupus erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 35; within 2 weeks after full remobilisation following surgery)
- •-hypertension, i.e. systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg
- •-disturbance of liver function: e.g. cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous oestrogen use, Rotor syndrome and Dubin-Johnson syndrome
- •-known or suspected hormone-dependent tumours or endometrial hyperplasia
- •-undiagnosed vaginal bleeding
- •-porphyria
- •-a history during pregnancy or previous hormone-use of severe pruritus, herpes gestationis or deterioration of otosclerosis
- •Use of one or more of the following medications:
- •-sex steroids other than the medication of study
- •-use at present or within 2 months before start study medication:
- •-hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin and St. John’s wort (Hypericum perforatum)
- •Status post-partum or post-abortion within a period of 2 months before study start
- •Administration of investigational drugs within 3 months before start study medication
- •A history of (within 12 months) alcohol or drug abuse
- •A known hypersensitivity for one of the components of the study medication (eg arachisoil and lactosis)
研究者
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