EUCTR2010-019902-17-DE进行中（未招募）不适用
A multicenter, open-label, randomized, controlled, two-arm study to assess compliance with daily tablet intake of women on treatment with the oral contraceptive SH T00186D/BAY 86-5300 (0.02 mg ethinyl estradiol as betadex clathrate and 3 mg drospirenone) in a flexible extended regimen supported by a dispenser (CADDY) with a reminder function over 12 months - EU-Compliance by buzzer study of YAZ Flex in the CADDY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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 subjects requesting contraception
- •3)Age between 18 and 35 years (inclusive), smokers must not be older than 30 years at the time point of informed consent
- •4)Normal or clinically insignificant 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). Subjects with ASCUS can be included if they are negative for high-risk HPV strains. (HPV testing in subjects with ASCUS will be used as an adjunctive test).
- •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
- •- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- •- Body mass index (BMI) >=30.0 kg/m2
- •- Presence or a history of venous or arterial thrombotic/thromboembolic events
- •- Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
- •- Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use
- •- Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
- •- Severe dyslipoproteinemia
- •- Malignant or premalignant disease
- •- Uncontrolled thyroid disorder
- •- Chronic inflammatory bowel disease
- •- Severe renal insufficiency or acute renal failure
- •- History of migraine with focal neurologic symptoms
- •- Epilepsy
研究者
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