EUCTR2016-003830-26-DE进行中（未招募）1 期
Single center, phase II, open label randomized clinical trial to evaluate the inhibition of ovulation of three prolonged release formulations containing a combination of Dienogest and Ethinyl Estradiol versus a flexible regimen contraceptive containing drospirenone 3mg and Ethinyl Estradiol 20µg in 100 healthy women.
Exeltis France0 个研究点目标入组 100 人开始时间: 2016年12月14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
- 100
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •01. Females (18 to 35 years of age, inclusive) without uncontrolled concomitant disease
- •02. Body Mass Index (BMI) of =18 Kg/m2 and =30 kg/m2
- •03. For smokers: not older than 30 years, inclusive; and not more than 10 cigarettes daily
- •04. Subjects must have a history of regular cycles
- •05. Subjects must consent to use reliable non-hormonal contraceptive methods (spermicide-coated condoms, diaphragm, female or male sterilization or sexual abstinence) throughout the study
- •06. Both ovaries must be visible on Transvaginal Ultrasound (TVU)examination during screening
- •07. Subjects must be in good physical and mental health as determined by vital signs, medical history (no history of a cervical smear PAP =3 within the last year) and gynaecological examination
- •08. Subjects must have a blood pressure after resting for 5 minutes between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic)
- •09. Subjects must have a pulse rate after resting for 5 minutes between 48 and 100 beats per minute (bpm)
- •10. Signed informed consent prior to study participation in accordance with the legal requirements and oral confirmation of the volunteer’s health insurance coverage
- •11. Status at least 3 months after a delivery, abortion, or lactation before screening
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •01. Pregnancy, a positive serum ß-hCG pregnancy test at screening or lactation
- •02. Known or suspected malign tumours or history thereof; subjects with cervical cytological smear classified higher than PAP II according to Papanicolaou grading scale I – IV have to be excluded (PAP II K can be controlled after an anti-inflammatory therapy up to 1 week after ending of this therapy)
- •03. History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis,
- •pulmonary embolism, stroke or myocardial infarction)
- •04. Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of an investigational drug or any study condition
- •05. Clinical relevant findings from serum biochemistry and haematology and HBsAg and C
- •Virus/HIV serology as evaluated by the investigator
- •06. Clinically relevant electrocardiogram (ECG) findings
- •07. Anovulatory precycle, or no ovulation by Day 27 of the precycle, or sonographical peculiarities concerning the ovarian status (e.g. ovarian cyst formation, that have not disappeared duringthe precycle)
- •08. Additional contraindications related to the use of dienogest (DNG) and/or drospirenone
- •(DRSP) and/or ethinylestradiol (EE):
- •- Volunteers with a history of incompatibility regarding the use of oral contraceptives
- •- Volunteers with high risk of venous thromboembolism due to presence of multiple risk factors. See risk factors in Section 4.4 of current SmPC for Velmari® Langzyklus 0.02/3 mg tablets dated December 2016
- •- Family history of thromboembolic diseases in close relatives that occurred at an age younger than 50 years
- •- Known medical factors coming along with an increased risk of venous and/or arterial thromboembolism as e.g. systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease, severe hyperlipidaemia and dyslipoproteinaemia
- •- History of migraine with focal neurological symptoms
- •- Known hereditary or acquired predisposition for venous and/or arterial
- •thromboembolism (e.g. activated protein C (APC) resistance, anticardiolipinantibodies)
- •- Less than 2 weeks remobilisation after major surgery or prolonged immobilisation
- •09. Alcohol, drug, or medicine abuse or suspicion thereof
- •10. Volunteer is a dependent person, e.g. a relative, family member, or member of the
- •investigator’s or sponsor’s staff
- •11. Volunteer is in custody or submitted to an institution due to a judicial order
- •12. Donation of blood or plasmapheresis after signing the informed consent
- •13. Known allergy to any ingredient of the investigational drug
- •14. Use of long-acting injectable or implant hormonal therapy within six months prior to the precycle
- •15. Use of hormonal or non-hormonal IUDs within one month prior to the start of precycle
- •16. Participation in another clinical trial at same time or within the preceding three months (calculated from the date of the last IMP intake)
- •17. Not fulfilling study specific requirements at screening
- •18. Any condition that, in the opinion of the investigator may jeopardize the trial conduct
- •according to the protocol
- •19. Regular intake or use of the following medication:
- •- any drugs that might interfere with the investigational drug
- •- any hormonal preparation one cycle prior to the start of the precycle until the end of
- •treatment cycles (except for the investigational drug or treatment for thyroid disorders
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