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临床试验/NCT01185678
NCT01185678已完成不适用

Observation of Compliance With Dosage in Women Using Oral Contraceptives Designed for the Non Stop Use, (it Means 28 Pills for 28-days Cycle).

Bayer0 个研究点目标入组 8,416 人开始时间: 2010年5月最近更新:
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
8,416
主要终点
The percentage of users showing noncompliant behaviors

研究概览

简要总结

Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.

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

入选标准

  • Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician.

排除标准

  • Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.

研究组 & 干预措施

Group1

干预措施: Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill) (Drug)

结局指标

主要结局

The percentage of users showing noncompliant behaviors

时间窗: 3 consecutive cycles (28-days per cycle)

次要结局

  • The characteristics of noncompliant behavior.(3 consecutive cycles (28-days per cycle))
  • The relation between noncompliant behavior and selected factors.(3 consecutive cycles (28-days per cycle))

研究者

发起方
Bayer
申办方类型
Industry

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