Zydus Healthcare gets CDSCO panel nod to study Dydrogesterone film coated Sustained Release Tablets

Written by Dr. Divya Colin Published On 2023-02-17T18:00:25+05:30 | Updated On 17 Feb 2023 12:30 PM GMT

Zydus Healthcare gets CDSCO panel nod to study Dydrogesterone film coated Sustained Release Tablets

New Delhi: Suggesting to monitor the size of endometrioma during the study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to drug major Zydus Healthcare for phase III clinical trial to assess the efficacy and safety of Dydrogesterone film coated sustained release tablets 20 mg as compared to Dydrogesterone tablets 10mg for the treatment of endometriosis in women.

This came after the firm represented the Phase III clinical trial protocol BIOS/2022/267, version No. 01 dated 06.10.2022.

Regarding the study, the firm added, “Prospective, randomized, double-blind study, single dummy, two-arm, active-controlled, parallel, multicentre, Phase III clinical trial to assess the efficacy and safety of Dydrogesterone film coated sustained release tablets 20 mg as compared to Dydrogesterone tablets 10mg for the treatment of endometriosis in women.”

Endometriosis is a disease characterized by the presence of tissue resembling endometrium (the lining of the uterus) outside the uterus. It causes a chronic inflammatory reaction that may result in the formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body.

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

At the recent SEC meeting for Reproductive & Urology held on 31st January 2023, the expert panel reviewed the Phase III clinical trial protocol BIOS/2022/267, version No. 01 dated 06.10.2022.

After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial. The committee also suggested to monitor the size of endometrioma during the study.

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.