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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.

Sneha Bhoir·Jaldhara Patel·Tushar Palve·Mrinal Kanti Dash·Sweety Saigal·Gourisankar Kamilya·Shalini Srivastava·Kartikbhai Savalia·Tanusree Gupta·Deepa Choudhary·Manohar Rangaswamy·Vidya V Bhatt·Neena Gupta·Malathi Ponnuru·Parul Shah·Apurva Shetty·Shruti Saha·Reshma Quadros·Sucheta Pandit·Dipak Patil·Piyush Patel·Pravin Ghadge·Lalit Lakhwani·Suyog Mehta·Sadhana Joglekar
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Abstract

OBJECTIVE: To compare the efficacy, safety and tolerability of elagolix with dienogest in women with moderate-to-severe endometriosis-associated pain. DESIGN: A multicentre, double-blind, double-dummy, randomised, parallel-group, active-controlled, non-inferiority phase III study. SETTING: Nineteen clinical centres across India. STUDY POPULATION: Women (18-49 years) diagnosed with endometriosis and experiencing moderate-to-severe pain. METHODS: Participants were randomised (1:1) to receive oral elagolix (150 mg once daily) or dienogest (2 mg once daily) for 24 weeks. OUTCOME MEASURES: The primary outcome was change in endometriosis-related pain (Numeric Rating Scale [NRS]) from baseline to Day 85. Secondary outcomes included changes in NRS (Day 169), dysmenorrhoea, non-menstrual pelvic pain (NMPP) scores (Days 85 and 169), rescue medication use, patient global impression of change (PGIC), adverse events and bone mineral density. RESULTS: Of 340 patients screened, 230 were randomised (115 per group). At Day 85, both arms showed similar reductions in NRS pain scores with a treatment difference of 0.04 (95% CI: -0.3, 0.37) [p = 0.9747] demonstrating non-inferiority as upper 95% CI was below pre-specified margin of 1.5. At Day 169, both arms showed comparable improvements in overall pain, dysmenorrhoea and NMPP from baseline (p = 0.9372, p = 0.8884, and p = 0.9616, respectively). Rescue medication use and PGIC were comparable between treatment arms. Adverse event incidence was similar (elagolix: 14.8%; dienogest: 19.1%), with no serious TEAEs or discontinuations. No significant bone mineral density changes were observed. CONCLUSIONS: Elagolix demonstrated non-inferiority to dienogest with an acceptable safety and tolerability profile, supporting its use in managing endometriosis-associated pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier: CTRI/2023/01/049292.

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HumansFemaleNandroloneEndometriosisDouble-Blind MethodAdultPelvic PainMiddle AgedHydrocarbons, FluorinatedPyrimidinesTreatment OutcomeYoung AdultAdolescentPain MeasurementIndiaGnRH antagonistdienogestelagolixendometriosisJournal ArticleMulticenter StudyClinical Trial, Phase IIIRandomized Controlled TrialEquivalence TrialComparative Study

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Sneha Bhoir, Jaldhara Patel, Tushar Palve, Mrinal Kanti Dash, Sweety Saigal, Gourisankar Kamilya, Shalini Srivastava, Kartikbhai Savalia, Tanusree Gupta, Deepa Choudhary, Manohar Rangaswamy, Vidya V Bhatt, Neena Gupta, Malathi Ponnuru, Parul Shah, Apurva Shetty, Shruti Saha, Reshma Quadros, Sucheta Pandit, Dipak Patil, Piyush Patel, Pravin Ghadge, Lalit Lakhwani, Suyog Mehta, Sadhana Joglekar. 2026-05-11. 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.. https://doi.org/10.1111/1471-0528.70256

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Adolescent subjectAdult subjectClinical Trial, Phase III subjectComparative Study subjectDouble-Blind Method subjectEquivalence Trial subjectFemale subjectHumans subjectIndia subjectJournal Article subjectMiddle Aged subjectMulticenter Study subjectPain Measurement subjectRandomized controlled trials study

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