NCT00998257已完成不适用
Regulatory Post Marketing Surveillance Study on YAZ
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 770
- 主要终点
- Release of Premenstrual Dysphoric Disorder (PMDD) or acne
研究概览
简要总结
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female subjects
- •requesting contraception
- •suggesting PMDD by Physician who are also requesting contraception
- •with acne who are also requesting contraception
- •Age: 18 - 50 years
- •Women who is prescribed YAZ first, during study period
排除标准
- •Women who are contraindicated based on the label of YAZ
- •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
- •Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
- •History of migraine with focal neurological symptoms
- •Diabetes mellitus with vascular involvement
- •The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
- •Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- •Presence or history of severe hepatic disease as long as liver function values have not returned to normal
- •Severe renal insufficiency or acute renal failure
- •Presence or history of liver tumours (benign or malignant)
- •Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
- •Undiagnosed vaginal bleeding
- •Known or suspected pregnancy
- •Hypersensitivity to the active substances or to any of the excipients
研究组 & 干预措施
Group 1
干预措施: EE20/DRSP (YAZ, BAY86-5300) (Drug)
结局指标
主要结局
Release of Premenstrual Dysphoric Disorder (PMDD) or acne
时间窗: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Contraception efficacy
时间窗: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Adverse event collection
时间窗: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Drug compliance
时间窗: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
次要结局
- Number of patients who used YAZ just for contraception(At initial visit (Day 0))
- Number of patients who used YAZ for Acne + contraception(At initial visit (Day 0))
- Number of patients who used YAZ for PMDD + contraception(At initial visit (Day 0))
研究者
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