Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

NCT07532876 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 17092025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Pain Score (Reduction in Pain)

  Primary outcomes will focus on patient-reported levels of dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Each primary outcome will be evaluated by using numerical pain scale (NRS), ranging from 0 (no pain) to 10 (worst pain). These pain scores are scheduled to be recorded at baseline (week 0), mid-treatment (week 12) and at end of treatment (week 24). Any adverse events occurring during this duration will also be documented.

  24 weeks

Study Arms (2)

Elagolix Group

EXPERIMENTAL

45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study.

Drug: Elagolix

OCPs group

EXPERIMENTAL

45 Participants in this group. OCPs will be administered once daily in a continuous 28-day cycles for 3 months.

Drug: Oral Contraceptive (OC)

Interventions

Elagolix DRUG

Elagolix will be administered at 150 mg once daily in this study.

Elagolix Group

Oral Contraceptive (OC) DRUG

In this study, administered once daily in a continuous 28-day cycles for 3 months

OCPs group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years
• clinically or surgically confirmed endometriosis
• having regular menstrual cycles
• willingness to participate with informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Endometriosis; Disease

Interventions

elagolix; Contraceptives, Oral

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

PA (1)