EUCTR2010-024546-30-DE进行中（未招募）不适用
Randomized, Open-Label Study to Evaluate the Influence on the Ovarian Activity, and the Cervix Score Over Two Treatment Cycles of 4.0 mg Drospirenone Daily for 24 Days as Compared to 0.075 mg Desogestrel Daily for 28 Days in 60 Healthy, Young Females - None
aboratories León Farma S.A.0 个研究点开始时间: 2011年12月23日最近更新:
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
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 premenopausal females of any ethnic origin (18 to 35 years of age, inclusive) without regular intake of medicine
- •Body Mass Index (BMI) of 18-30 kg/m2, inclusive
- •Subjects must consent to use reliable non-hormonal contraceptive methods (spermicide-coated condoms, diaphragm, female or male sterilization or sexual abstinence) throughout the study
- •Subjects must be in good physical and mental health as determined by vital signs, medical history, physical examination, gynaecological examination, cervical smear, urinalysis, serum biochemistry, HBsAg/HCV/HIV serology, and haematology
- •Subjects must have a blood pressure after resting for 5 minutes between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic) and a pulse rate of = 100 beats per minute (bpm)
- •Subjects must have voluntarily signed informed consent
- •Status at least three months after a delivery, abortion, or lactation before screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy, a positive urine pregnancy test or lactation
- •Known or suspected malign tumours or history thereof; subjects with cervical cytological smear classified higher than PAP II according to Papanicolaou grading scale I – V have to be excluded (PAP II K can be controlled after an anti-inflammatory therapy up to 4 weeks after start of this therapy)
- •Thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction) or other conditions that increase susceptibility to thromboembolic diseases (e.g. prolonged immobilization, disturbance of the coagulation system or thromboembolic diseases in a close relative at young age, certain heart diseases)
- •Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of an investigational drug or any study condition, e.g. lactose-intolerance
- •Additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalaemia): renal or adrenal insufficiency or hepatic dysfunction
- •Anovulatory precycle or sonographical peculiarities concerning the ovarian status (e.g. ovarian cyst formation, that have not disappeared during the precycle)
- •Alcohol, drug, or medicine abuse or suspicion thereof
- •Participation in a further clinical study at the same time or intake of an investigational medicinal product within 4 weeks prior to screening
- •Volunteer is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff
- •Volunteer in custody or submitted to an institution due to a judicial order
- •Donation of blood or plasmapheresis after signing the informed consent
- •Known allergy to any ingredients of the investigational drug or reference drug
- •Intake of the following medication:
- •- any drugs that might interfere with the study objectives
- •- especially any drugs known to induce liver enzymes (e.g. rifampicin, dexamethasone, barbiturates, anticonvulsants, St. John’s wort)
- •- any drugs known to inhibit CYP 3A4 (e.g. ketoconazole, verapamil, cimetidine, macrolides)
- •- use of sex steroids during the cycle prior to the start of the precycle until the end of the post-treatment cycle (except for the study medication in the treatment cycles)
- •- use of long-acting injectable or implant hormonal therapy within 6 months prior to the start of precycle
- •- use of hormonal or non-hormonal IUDs within 1 month prior to the start of screening
研究者
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