A multicentre phase III study comparing efficacy and safety of novel extended-release versus conventional formulation of dydrogesterone in Indian patients with endometriosis

Authors

  • T. Sasikala Department of Gynaecology, Government Medical College and Government General Hospital (old RIMSSGH), Srikakulam, Andhra Pradesh, India
  • Shikha Kushwaha Department of Obstetrics and Gynecology, Prakhar Hospital Pvt Ltd, Kanpur, Uttar Pradesh, India
  • Mukta Agarwal Department of Obstetrics and Gynecology, All India Institute of Medical Science, Phulwari, Patna, Bihar, India
  • Vandana Jain Department of Gynecology, Unity Hospital, Ahmedabad, Gujarat, India
  • Deepti Bawa Department of Gynecology, Citizen Hospital, Bangalore, Karnataka, India
  • Suchitra Narayan Jawahar Lal Nehru Medical College, Ajmer, Rajasthan, India
  • Pavankumar Daultani New Product Development, Zydus Healthcare Limited, Ahmedabad, Gujarat, India
  • Ashok Jaiswal Medical Affairs, Zydus Healthcare Limited, Mumbai, Maharashtra, India
  • Monika Chinda Medical Affairs, Zydus Healthcare Limited, Mumbai, Maharashtra, India
  • Anit Singh Clinical Research Network, Noida, Uttar Pradesh, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20241298

Keywords:

Dydrogesterone, Endometriosis, Extended-release, Pelvic pain, Progesterone

Abstract

Background: The aim of the study was to compare the efficacy and safety of novel once-daily extended-release (ER) dydrogesterone 20 mg versus conventional twice-daily dydrogesterone 10 mg in Indian patients with endometriosis.

Methods: A phase III prospective, randomized, double-blind, single-dummy, two-arm, active-controlled, parallel, multicenter study was performed in six gynecology centers across India. The patients of 18 to 45 years of age with a confirmed diagnosis of endometriosis on ultrasonography (USG) and having endometriosis-associated pelvic pain score (EAPP) of at least 30 mm on a 100 mm visual analog scale (VAS) were randomly assigned to a 1:1 ratio to either once-daily dydrogesterone ER 20 mg or twice-daily dydrogesterone 10 mg arms for a treatment period of 90 days. The primary outcome was a change from baseline in EAPP score at the end of the treatment.

Results: A total of 228 patients with a mean age of 31.8±6.9 years were enrolled in the study. At day 90, both the treatment arms showed a significant reduction (p<0.05) in EAPP score from baseline (i.e. -34.2±15.3 mm and -33.1±14.8 mm in once daily dydrogesterone ER and twice daily dydrogesterone 10 mg, respectively), with no significant difference between the two arms (p=0.53). With both formulations, patients experienced a significant reduction in the size of endometrioma, serum vascular endothelial growth factors (VEGF) levels, use of rescue analgesics, and significant improvement in the health-related quality-of-life parameters. A favorable safety profile of dydrogesterone was confirmed, and no significant safety concerns were reported during the study.

Conclusions: Once daily dydrogesterone ER 20 mg and twice daily dydrogesterone 10 mg demonstrated a significant and similar reduction in EAPP and all other secondary parameters along with marked improvements in parameters related to quality of life.

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Published

2024-05-13

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Original Research Articles