German Remedies, a part of the Zydus group, along with Schering AG Germany world leader in female healthcare, is conducting a first-of-its kind menorrhagia trial in India.
According to the company release, this trial will assess and improve the quality of life of patients suffering from heavy menstrual bleeding for a prolonged duration and associated pain. It will also help generate local data through which the profile and history of patients can be monitored.
Nine countries will participate in the trial involving nearly 1,600 patients. The trial plans to treat around 200 women from across the country. The other countries include RRO Amman, Bulgaria, RRO Cairo, Croatia, Romania, Serbia-Montenegro, South Africa, Russia, Turkey, Pakistan and Kazakhstan.
During the trial, patients will be using Mirena (LNG_IUS), the latest non-operative option for menorrhagia. Mirena (LNG-IUS) is a unique intra uterine system, which releases 20 micro grams of levonorgestrel (LNG-a hormonal progesterone) daily for 5 years. It also acts as an effective contraceptive. The intrauterine release of LNG suppresses the endometrial epithelium, leading to a decreased number of bleeding days and decreased menstrual blood loss.
Mirena, which is being marketed by German Remedies, has been tried in a majority of patients suffering from heavy bleeding and has shown very satisfactory results. The trial initiation meeting will be conducted in Mumbai on the 22nd May and in Delhi on the 23rd May, release added.
"The study is being performed to assess the improvement in quality of life with Mirena use in menorrhagia patients. Indian gynaecologists have been invited to join this project in order to generate local data," says Dr. Martina Muttke, medical director for Schering AG.