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過多月経および月経困難症に対するミレーナの安全性に関する前向き非介入多施設共同研究

基本情報

NCT ID
NCT02475356
ステータス
完了
試験のフェーズ
-
試験タイプ
観察
目標被験者数
601
治験依頼者名
Bayer

概要

The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the first 12 months Mirena insertion. The secondary objective(s) in this study is/are collecting information on Mirena effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

対象疾患

Menorrhagia, Dysmenorrhea

介入

Levonorgestrel IUS (Mirena, BAY86-5028)(DRUG)

依頼者(Sponsor)