Endometriosis (Diagnosis)Phase 4NCT07532876
Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
A Phase 4 study testing Elagolix and Oral Contraceptive (OC) in people with Endometriosis (Diagnosis), run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis (Diagnosis)
- What is being tested?
- Elagolix and Oral Contraceptive (OC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 1 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years
- clinically or surgically confirmed endometriosis
- having regular menstrual cycles
- willingness to participate with informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Efficacy and Safety 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.
Read the 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.
- Conditions
- Endometriosis (Diagnosis)
- Being tested
- Elagolix, Oral Contraceptive (OC)
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElagolixDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Elagolix Group | Experimental | 45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study. Receives: 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. Receives: Drug: Oral Contraceptive (OC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Nisar, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532876
- Sponsor's protocol ID
- 17092025
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
- ClinicalTrials.gov ID
- NCT07532876
- Acronym / sponsor ID
- 17092025
- Conditions
- Endometriosis (Diagnosis)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elagolix Group | Experimental | Drug: Elagolix45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study. |
| OCPs group | Experimental | Drug: Oral Contraceptive (OC)45 Participants in this group. OCPs will be administered once daily in a continuous 28-day cycles for 3 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-45 years
- clinically or surgically confirmed endometriosis
- having regular menstrual cycles
- willingness to participate with informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElagolixElagolix will be administered at 150 mg once daily in this study. | Drug | Elagolix Group |
| Oral Contraceptive (OC)In this study, administered once daily in a continuous 28-day cycles for 3 months | Drug | OCPs group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elagolix and Oral Contraceptive (OC) in people with Endometriosis (Diagnosis), run by Pak Emirates Military Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (Reduction in Pain) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.