Comparison of Efficacy and Safety of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
| Registry | NCT07532876 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Phase 4 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | Pak Emirates Military Hospital (Other) |
| Conditions | Endometriosis (Diagnosis) |
| Interventions | Elagolix, Oral Contraceptive (OC) (Drug) |
| Dates | start 2026-05-01 (estimated), primary completion 2026-10-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-04-16, last updated 2026-04-16 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Endometriosis (Diagnosis) All trials of Elagolix All trials of Oral Contraceptive (OC)
This study is designed to provide direct evidence on the relative effectiveness and safety of Elagolix versus OCPs, helping physicians make more tailored treatment decisions.
Eligible patients will be assigned to one of two groups: Elagolix 150 mg once daily or OCPs daily, based on physician recommendation and patient preference. Baseline demographic and clinical information will be recorded. Pain outcomes (dysmenorrhea, dyspareunia, non menstrual pain) will be assessed on the NRS at baseline, 12 weeks, and 24 weeks. Adverse events will be documented throughout.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Elagolix Group | Experimental | Drug: Elagolix | 45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study. |
| OCPs group | Experimental | Drug: Oral Contraceptive (OC) | 45 Participants in this group. OCPs will be administered once daily in a continuous 28-day cycles for 3 months. |
Sex: Female, ages: 18 Years to 45 Years
Inclusion Criteria: * Women aged 18-45 years * clinically or surgically confirmed endometriosis * having regular menstrual cycles * willingness to participate with informed consent. Exclusion Criteria * Contraindications to OCPs (e.g., thromboembolism, cardiovascular disease, uncontrolled hypertension, smoking over age 35) * Contraindications to Elagolix (e.g., osteoporosis, pregnancy, hypersensitivity, severe depression) Prior hysterectomy or bilateral oophorectomy, Other identifiable causes of pelvic pain.
| Facility | City | Country | Status |
|---|---|---|---|
| Pak Emirates Military Hospital | Rawalpindi, Punjab Province | Pakistan |