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.

Dydrogesterone is an orally active progestogen that acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.

Estradiol is an estrogenic steroid used to treat vasomotor symptoms of vulvar and vaginal atrophy in menopause, hypoestrogenism, prevention of postmenopausal osteoporosis, treatment of breast cancer, and advanced androgen-dependent carcinoma of the prostate.

At the recent SEC meeting (Reproductive) held on 21st February 2024, the expert panel reviewed the revised Phase IV clinical trial protocol of the FDC Dydrogesterone plus Estradiol.

After detailed deliberation, the committee recommended a grant of permission to conduct the Phase IV clinical trial as per the revised protocol.

Following the above, the expert panel suggested that the firm should submit a Phase IV clinical trial report to CDSCO for further review by the committee.

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