NCT01331655撤回3 期
A Multicenter, Open-label, 3-arm, Active-controlled, Parallel-group, 1-year Study to Investigate the Efficacy and Safety of a Flexible Regimen of the Combined Oral Contraceptive, With and Without 0.451 mg Levomefolate Calcium (BAY98-7071 and BAY86-5300, Respectively) Versus the Standard 24 + 4 Regimen With Levomefolate (BAY98-7071 + BAY86-7660) and to Assess Compliance With a Device (CADDY) in Healthy Women Who Desire Contraception
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- Number of bleeding days
研究概览
简要总结
The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection
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 combined oral contraceptive (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
研究组 & 干预措施
Arm 1
Experimental
干预措施: EE20/DRSP (BAY86-5300) (Drug)
Arm 2
Experimental
干预措施: EE20/DRSP/L-5-MTHF (BAY98-7071) (Drug)
Arm 3
Active Comparator
干预措施: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660) (Drug)
结局指标
主要结局
Number of bleeding days
时间窗: Approximately 1 year
次要结局
- Bleeding pattern and cycle control parameters(Approximately 1 year)
- Number of cycles per subject(Approximately 1 year)
- Difference in the number of missed tablets between Arms A and B(Approximately 1 year)
研究者
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