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A study comparing two medicines Dienogest and Elagolix for reducing pain and improving quality of life in women with endometriosis.

Comparison of Dienogest and Elagolix in improving endometriosis associated pain and quality of life in women with endometriosis: An open label, double arm, randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093175
Enrollment
80
Registered
2025-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N809- Endometriosis, unspecified

Interventions

Intervention1: Elagolix: Group-2(Intervention) Drug-Elagolix Dose- 150 mg Route-Per oral Frequency-Once daily Duration- For 90 day Control Intervention1: Dienogest: Group-1(Comparator) Drug-Dienoges

Sponsors

Dr Susheela Godara
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 15-49 years having endometriosis diagnosed by symptoms, clinical findings and ultrasound Endometriosis associated pain like Dysmenorrhea, Pelvic pain, Dyspareunia Planned for medical management, less than 5cm endometrioma Willing to be part of the study

Exclusion criteria

Exclusion criteria: Asymptomatic endometrioma more than 5cm Patient planned for infertility treatments Scar endometriosis Contraindication to any of the two drug

Design outcomes

Primary

MeasureTime frame
Reduction in endometriosis-associated pain score at 3 months from baseline, measured by Numerical Rating Scale (0?10)Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks (?5 days)

Secondary

MeasureTime frame
1.Change in quality of life scores (EHP-30) at 3 months from baseline 2.Side effect profile of both drugs at 3 months.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks (?5 days)

Countries

India

Contacts

Public ContactDr Monika Anant

Aiims Patna

drmonikaa@aiimspatna.org7764946249

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026