Zydus Healthcare Gets CDSCO Panel To Study Dydrogesterone Extended-release Tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Zydus Healthcare to conduct the Phase III clinical trial and bioequivalence (BE) study of the synthetic progesterone, Dydrogesterone with the suggestion to monitor the size of the endometrioma in the participating subjects during the clinical trial.
In addition, the expert panel suggested the firm include more clinical trial sites in the study.
This came after the drug major Zydus Healthcare presented the application for manufacturing and marketing of Dydrogesterone film coated sustained release tablets 30mg for the indication “For the management of various conditions where the progesterone supplement is needed”.
The firm also presented the Phase III clinical trial protocol to assess the efficacy and safety of Dydrogesterone film coated sustained release tablets 30mg for the treatment of endometriosis in women and BE study protocol before the committee.
Endometriosis is a disease in which tissue similar to the lining of the uterus grows outside the uterus. It can cause severe pain in the pelvis and make it harder to get pregnant. Endometriosis can start during a person's first menstrual period and last until menopause.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions. A synthetic progestational hormone with no androgenic or estrogenic properties.
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. Furthermore, dydrogesterone is non-androgenic, non-estrogenic, non-corticoid, and non-anabolic and is not excreted as pregnanediol.
At the recent SEC meeting for Reproductive and Urology held on 26th April 2023, the expert panel reviewed the application for manufacturing and marketing of Dydrogesterone film coated sustained release tablets 30mg for the indication “For the management of various conditions where the progesterone supplement is needed” and Phase III clinical trial protocol to assess the efficacy and safety of Dydrogesterone film coated sustained release tablets 30mg for the treatment of endometriosis in women and BE study 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.
The committee also suggested monitoring the size of the endometrioma in the participating subjects during the clinical trial and more clinical trial sites should be included in the study.
Also Read: Bharat Biotech's intranasal Covid vaccine iNCoVACC gets CDSCO Panel nod for PMS study
