Zydus Healthcare gets CDSCO panel nod to study Dydrogesterone film coated Sustained Release Tablets
New Delhi: Suggesting to monitor the size of endometrioma during the study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to drug major Zydus Healthcare for phase III clinical trial to assess the efficacy and safety of Dydrogesterone film coated sustained release tablets 20 mg as compared to Dydrogesterone tablets 10mg for the treatment of endometriosis in women.
Endometriosis is a disease characterized by the presence of tissue resembling endometrium (the lining of the uterus) outside the uterus. It causes a chronic inflammatory reaction that may result in the formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions. Dydrogesterone is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus
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