Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elagolix, Oral Contraceptive (OC).
- Who it may be relevant to
- Registry conditions: Endometriosis (Diagnosis). Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Efficacy and Safety of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
Overview
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
- Drug Elagolix
Elagolix will be administered at 150 mg once daily in this study. - Drug Oral Contraceptive (OC)
In this study, administered once daily in a continuous 28-day cycles for 3 months
Primary outcome measures
- Pain Score (Reduction in Pain) [Time frame: 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Pak Emirates Military Hospital — Rawalpindi
Identifiers
NCT: NCT07532876 · 17092025