EUCTR2010-019902-17-IT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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