Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

NCT07532876 — Phase 4, Enrolling by invitation, 90 participants, Pak Emirates Military Hospital

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

RegistryNCT07532876
StatusEnrolling by invitation
PhasePhase 4
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment90 (Estimated)
SponsorPak Emirates Military Hospital (Other)
ConditionsEndometriosis (Diagnosis)
InterventionsElagolix, Oral Contraceptive (OC) (Drug)
Datesstart 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
Locations1 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)

-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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Elagolix GroupExperimentalDrug: Elagolix45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study.
OCPs groupExperimentalDrug: Oral Contraceptive (OC)45 Participants in this group. OCPs will be administered once daily in a continuous 28-day cycles for 3 months.
  • 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

+Outcome measures

Primary outcomes

  • Pain Score (Reduction in Pain) [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.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Pak Emirates Military HospitalRawalpindi, Punjab ProvincePakistan