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.
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.
The drug is mainly used to relieve pain and menstrual cramps. It is also used to treat endometriosis, a condition that shows symptoms like abdominal pain and menstrual irregularities. The medication is also used for the treatment of secondary amenorrhea (a condition where menstruation has stopped due to the absence of pregnancy and menopause). Also, Dydrogesterone is used to treat various disorders like dysfunctional uterine bleeding, premenstrual syndrome, threatened abortion, habitual abortion, infertility due to luteal insufficiency, and hormone replacement therapy.
At the recent SEC meeting for Reproductive & Urology held on 25th May 2023, the expert panel reviewed the proposal presented by drug major Abbott for manufacturing and marketing of the Dydrogesterone Sustained release tablet 20 mg with the BE study and Phase III clinical trial protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial and BE study as per the protocol presented with the condition that the firm should include more clinical trial sites and that the sites should be geographically distributed across the country.
In addition, the expert panel further suggested that the firm should monitor the size of the endometrioma of participating subjects during the clinical trial.
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