Monitor endometrioma size of clinical trial participants: CDSCO panel tells Abbott India on Dydrogesterone
New Delhi: Suggesting monitoring the size of the endometrioma of participating subjects during the clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug major Abbott India to conduct the Phase III clinical trial and bioequivalence (BE) study of Dydrogesterone Sustained Release Tablets 20mg, an orally active progestogen that acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus.
However, this nod is subject to the condition that the firm should include more clinical trial sites and the sites should be geographically distributed across the country.
This came after the firm presented the proposal for manufacturing and marketing of Dydrogesterone Sustained release tablet 20mg with the BE study and Phase III clinical trial protocol.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions.
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