Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07532876

Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Endometriosis (Diagnosis) Disease Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elagolix

Drug

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

Oral Contraceptive (OC)

Drug

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

Primary outcomes

  1. Pain Score (Reduction in Pain)

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Pak Emirates Military Hospital

Other

Registry information

Official study title

Comparison of Efficacy and Safety of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.