临床试验/NCT01375998

NCT01375998已完成不适用

Drug Use Investigation of YAZ

Bayer0 个研究点目标入组 3,273 人开始时间: 2011年6月9日最近更新: 2019年3月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 3,273
主要终点: Incidence of adverse drug reactions and sever adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: Female
接受健康志愿者: 否

入选标准

•Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
•Patient informed consent

排除标准

•Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire
•Six months or less after treatment of estrogen or estrogen combination drug

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

Incidence of adverse drug reactions and sever adverse events

时间窗: During YAZ administration, up to 3 years

Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)

时间窗: Baseline and during YAZ administration, up to 3 years

次要结局

Unpleasant physical symptoms collection(Baseline and during YAZ administration, up to 3 years)
Unpleasant psychological symptoms collection(Baseline and during YAZ administration, up to 3 years)
Incidence of adverse events(During YAZ administration, up to 3 years)
Analgesic drug for dysmenorrhea(During YAZ administration, up to 3 years)
QOL survey using Short-Form 36-Item Health Survey (SF-36)(Baseline and at 6th - 8th cycles (28 datys per cycle))

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

不适用

Zevalin Post-marketing Surveillance in JapanNon-Hodgkin's Lymphoma (NHL)

NCT01448928Spectrum Pharmaceuticals, Inc400

已完成

不适用

Magnevist Post-marketing Surveillance in JapanDiagnostic Imaging

NCT01376739Bayer2,051

已完成

不适用

Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or DysmenorrheaEndometriosis and Dysmenorrhea

NCT03126747Bayer715

已完成

不适用

Mirena Post-marketing Surveillance in JapanContraception

NCT01414140Bayer567

已完成

不适用

Primovist Post-marketing Surveillance in JapanDiagnostic Imaging

NCT01411449Bayer2,030