EUCTR2009-010599-45-DE进行中（未招募）1 期
Single-center, open-label, uncontrolled study to investigate the effects of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) on the endometrium in a 21-day regimen for 13 cycles in 80 healthy women - Transdermal contraceptive patch - endometrial effects study
适应症
试验速览
- 阶段
- 1 期
- 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
- •1.Signed and dated informed consent
- •2.Healthy woman requesting contraception
- •3.Age: 18 – 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
- •4.Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- •5.History of regular cyclic menstrual periods
- •6.Normal endometrial biopsy not requiring further follow-up.
- •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
- •1.Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
- •2.Obesity (Body Mass Index > 30.0 kg/m2)
- •3.Hypersensitivity to any ingredient of the study drug
- •4.Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- •5.Safety relevant laboratory values outside inclusion range before start of treatment
- •6.Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
- •7.Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •8.Any disease or condition that may worsen under hormonal treatment such as:
- •Cardiovascular
- •-presence or a history of venous or arterial thrombotic/thromboembolic events or of a cerebrovascular accident, including prodromi and conditions that could increase the risk to suffer from any of the above mentioned disorders
- •-repeated measurements of systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg
- •-presence or history of liver tumors (benign or malignant)
- •-presence or history of severe hepatic disease as long as liver function values have not returned to normal
- •-jaundice and/or pruritus related to cholestasis (Gilbert’s syndrome excepted)
- •-history of cholestatic jaundice associated with pregnancy or previous COC use
- •Metabolic diseases
- •-uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
- •-severe dyslipoproteinemia
- •Other diseases
- •-malignant or premalignant disease
- •-uncontrolled thyroid disorder
- •-severe renal insufficiency or acute renal failure
- •-history of hypertriglyceridemia-associated pancreatitis
- •-pemphigoid gestationis during a previous pregnancy
- •-history of herpes gestationis
- •-otosclerosis-related hearing loss
- •-history of migraine with focal neurologic symptoms
- •-clinically significant depression
- •-hereditary angioedema
- •9.Undiagnosed abnormal genital bleeding
- •10.Abuse of alcohol, drugs, or medicines (e.g., laxatives)
- •11.Other contraceptive methods:
- •-long-acting preparations
- •12.Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
- •13.Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
- •14.Major surgery scheduled during the study period
- •15.Subject is a dependent person
- •16.Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site.
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