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

T. Sasikala, Shikha Kushwaha, Mukta Agarwal, Vandana Jain, Deepti Bawa, Suchitra Narayan, Pavankumar Daultani, Ashok Jaiswal, Monika Chinda, Anit Singh
In: International Journal of Reproduction, Contraception, Obstetrics and Gynecology · 2024 · vol. 13(6) , pp. 1425–1431 · doi:10.18203/2320-1770.ijrcog20241298 · W4396902896
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This multicenter study found that once-daily extended-release dydrogesterone was as effective and safe as twice-daily conventional dydrogesterone in reducing pelvic pain and endometrioma size in Indian patients.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-08 ⓘ

This multicentre phase III randomized, double-blind, single-dummy trial in 228 Indian women aged 18–45 with ultrasound-confirmed endometriosis compared once-daily extended-release (ER) dydrogesterone 20 mg versus conventional twice-daily dydrogesterone 10 mg over 90 days, using change in endometriosis-associated pelvic pain score (EAPP) as the primary endpoint. At day 90, both groups showed significant reductions in EAPP from baseline (-34.2±15.3 mm and -33.1±14.8 mm, respectively) with no significant difference between formulations (p=0.53), and both were associated with reduced endometrioma size, lower serum VEGF levels, reduced rescue analgesic use, and improved health-related quality-of-life measures. The safety profile was described as favorable with no significant safety concerns reported, though the abstract does not specify longer-term outcomes beyond the 90-day treatment period. This paper is centrally about endometriosis — it directly evaluates extended-release versus conventional dydrogesterone for endometriosis-associated pelvic pain and related biomarkers in affected patients.

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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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VAS-pain

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endometriosisendometrioma

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