CDSCO Panel Tells Abbott India to revise phase IV CT protocol of Dydrogesterone plus Estradiol Tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Abbott India to revise the Phase IV clinical trial protocol of the fixed-dose combination (FDC) of Dydrogesterone plus Estradiol in accordance with In inclusion criteria, primary endpoint, secondary endpoint.
In addition, the expert panel stated that the objective criteria need to be defined for mild, moderate, and severe hot flashes depending on quality of life (QOL) scale scoring.
This came after Abbott India presented the revised Phase IV clinical trial protocol of Dydrogesterone plus Estradiol ( 2.5 mg plus 0.5mg) tablets before the committee.
Dydrogesterone is a synthetic progestogen that works similarly to progesterone (female hormone). It is used to treat menstrual disorders caused by a lack of hormones in women. It's also used to help prevent miscarriages and abortions. The drug is used mainly to relieve pain and menstrual cramps.
Estradiol has several functions in the female body. Its main function is to mature and then maintain the reproductive system. During the menstrual cycle, increased estradiol levels cause the maturation and release of the egg, as well as the thickening of the uterus lining to allow a fertilized egg to implant.
Estradiol plus Dydrogesterone is used as a part of hormone replacement therapy to relieve symptoms of menopause.
At the recent SEC meeting for reproduction and urology held on 30th August 2023, the expert panel reviewed the revised Phase IV clinical trial protocol of the FDC Dydrogesterone plus Estradiol presented by the drug major Abbott India.
After detailed deliberation, the committee recommended to revise the following in Phase IV clinical protocol:
1. In Inclusion criteria- seven or more hot flushes over the past 7 days during the 2-week screening period should be replaced by “having an impact on quality of life”.
2. Primary endpoint - Change in quality of life (QOL) scoring.
3. Secondary endpoint -Change in the frequency of hot flushes from baseline.
4. Objective criteria need to be defined for mild, moderate, and severe hot flushes depending on QOL scale scoring.
Accordingly, the committee suggested that the firm should submit a revised Phase IV clinical trial protocol for review by Drugs Controller General of India (DCGI).
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