Abbott gets CDSCO Panel Nod To study FDC Dydrogesterone plus Estradiol
New Delhi: The drug major Abbott has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed-dose combination (FDC) Dydrogesterone IP 2.5mg plus Estradiol 0.5mg tablets.
This came after the drug maker Abbott presented a revised Phase IV clinical trial protocol before the committee.
Estradiol plus Dydrogesterone is a combination of two hormonal medicines: Estradiol and Dydrogesterone which are a part of hormone replacement therapy (HRT). Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular, or painful menstrual periods, infertility, premenstrual syndrome, and endometriosis.
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