EUCTR2008-004214-27-DE进行中（未招募）不适用
Multi-center, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects - EU/LA/AUS Pearl Index study – transdermal contraceptive patch
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,650
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 female subject 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
- •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 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. 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 (e.g., known skin disease with
- •suspected alteration of dermal absorption or poor adherence of the patch such as
- •6. Any diseases or conditions that might interfere with the conduct of the study or
- •the interpretation of the results
- •7. Any disease or condition that may worsen under hormonal treatment such as:
- •Cardiovascular
- •- 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, including prodromi (e.g., transient ischaemic attack,
- •angina pectoris) and conditions that could increase the risk to suffer from any of
- •the above mentioned disorders, e.g., a family history indicating a hereditary
- •predisposition
- •- 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
- •- epilepsy
- •- clinically significant depression
- •- hereditary angioedema
- •8. Undiagnosed abnormal genital bleeding
- •9. Abuse of alcohol, drugs, or medicines (e.g., laxatives)
- •10. Other contraceptive methods:
- •- sterilization
- •- oral, vaginal, or transdermal hormonal contraception during treatment
- •- intrauterine devices (IUDs) with or without hormone release
- •- implants
- •- long-acting preparations (e.g., Depot-MPA, monthly contraceptive injection)
- 另有 8 项未显示
研究者
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