The Hindu Business Line : German Remedies trial on Schering device

German Remedies will be part of a global phase IV trial or a post marketing surveillance on German company Schering's intra-uterine contraceptive device Mirena. German Remedies is part of the Zydus group and the trial plans to treat 200 women from across the country, a note from German Remedies said.

Nine countries will participate in the trial involving nearly 1,600 patients. Other countries include Bulgaria, Croatia, Romania, South Africa, Russia, Turkey, Pakistan and Kazakhstan.

During the trial, patients will use Mirena, marketed in India by German Remedies. The trial initiation meeting will be conducted in Mumbai on May 22 and in the Capital the next day.

Patients involved in the trial will be monitored for a period of one year. After the insertion of Mirena (LNG-IUS), they will undergo a follow-up on the third, sixth and 12th month, the note said. The study is being performed to assess improvement in the quality of life with Mirena use in menorrhagia patients. Indian gynaecologists have been invited to join this project to generate local data, the statement says quoting Dr Martina Muttke, Medical Director for Schering AG.

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