Gynecology World Conference 2026

Abstract

Background: Endometriosis is a chronic estrogen-dependent inflammatory disorder affecting approximately 6–10% of reproductive-aged women and is frequently associated with chronic pelvic pain, dysmenorrhea, dyspareunia, infertility, adenomyosis, and ovarian endometriomas. Existing medical therapies are often limited by hypoestrogenic adverse effects, poor tolerability, recurrence after discontinuation, or invasive surgical requirements. Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, has demonstrated efficacy in reducing endometriosis-associated pain in randomized clinical trials; however, Indian real-world Indian data across heterogeneous phenotypes such as adenomyosis and ovarian endometrioma remains limited. This study evaluated the effectiveness and safety of Elagolix in Indian women with endometriosis in routine clinical practice.

This is an ongoing prospective, multicentric, observational real-world evidence study conducted in premenopausal Indian women with symptomatic endometriosis confirmed on ultrasonography. Patients received Elagolix 150 mg once daily or 200 mg twice daily as per routine clinical practice. Clinical assessments were performed at baseline, Month 3, and Month 6. The primary endpoint was change in endometriosis-associated pain assessed using the Visual Analogue Scale (VAS). Secondary endpoints included changes in lesion size, cyst volume, uterine volume, safety, tolerability, and treatment adherence. Interim analysis included 11 women who completed at least 3 months of follow-up.

Methodology: This is an ongoing prospective, multicentric, observational real-world evidence study conducted in premenopausal Indian women with symptomatic endometriosis confirmed on ultrasonography. Patients received Elagolix 150 mg once daily or 200 mg twice daily as per routine clinical practice. Study assessments were performed at baseline, Month 3, and Month 6. The primary endpoint was change in endometriosis-associated pain assessed using the Visual Analogue Scale (VAS) for congestive dysmenorrhea, non-menstrual pelvic pain, and dyspareunia at Month 3. Secondary endpoints included radiological changes in lesion size, cyst volume, uterine volume, safety, tolerability, and treatment adherence. Interim analysis included 11 women who completed at least 3 months of follow-up.

Results: At Month 3, Elagolix demonstrated clinically meaningful improvement across pain domains. Mean VAS score for congestive dysmenorrhea reduced significantly from 8.64 to 3.45 (mean reduction 5.18; p=0.001). Non-menstrual pelvic pain improved from 5.80 to 2.00, while dyspareunia improved from 5.50 to 3.50. Radiological assessment demonstrated significant reduction in ovarian endometriotic cyst size (mean reduction 5.3 mm; p=0.031), with median cyst volume reduction of 4.7 mL. Among patients with adenomyosis, mean endometrial thickness reduced from 31.0 mm to 6.6 mm by Month 3, along with trends toward reduction in uterine volume. A composite responder analysis demonstrated that all patients achieved ≥30% pain reduction, while 7 of 11 patients also demonstrated ≥20% radiological lesion regression. Elagolix was generally well tolerated. No serious adverse events or treatment discontinuations due to adverse events were reported. Adverse events were mild to moderate and consistent with the known hypoestrogenic profile of Elagolix. High treatment adherence was observed.

Conclusion: Interim real-world data suggest that Elagolix provides rapid and clinically meaningful pain relief with encouraging radiological improvement and good tolerability in Indian women with endometriosis. These findings support the effectiveness and feasibility of Elagolix in routine clinical practice across diverse endometriosis phenotypes.