Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

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

Status

Enrolling by invitation

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07532876

Enrollment

Registered

2026-04-16

Start date

2026-05-01

Completion date

2026-11-01

Last updated

2026-04-16

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

Conditions

Endometriosis (Diagnosis)

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.

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.

Interventions

DRUGElagolix

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

DRUGOral Contraceptive (OC)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026