Efficacy and Safety of Elagolix Versus Dienogest for Treatment of Moderate-to-Severe Endometriosis Pain: A Phase III, Multicentric, Double-Blind, Active-Controlled, Non-Inferiority Study.

In 30 seconds

This phase III, multicenter, double-blind, randomized controlled trial compared elagolix and dienogest in women aged 18-49 with moderate-to-severe endometriosis pain. Both treatments showed similar reductions in pain scores at Day 85, with a treatment difference of 0.04 (95% CI: -0.3, 0.37) [p = 0.9747], confirming non-inferiority.

Key findings

• At Day 85, elagolix and dienogest had a treatment difference of 0.04 in NRS pain scores.
• Both treatments showed comparable improvements in dysmenorrhoea and NMPP at Day 169 (p = 0.8884 and p = 0.9616, respectively).
• Adverse event incidence was similar: 14.8% for elagolix and 19.1% for dienogest.

Why it matters

The findings support the use of elagolix as a viable alternative to dienogest for managing endometriosis-associated pain, providing clinicians with more treatment options for their patients.