Can common endometriosis drugs change blood flow in the brain?

NCT ID NCT07799246

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial asks whether two medications used for endometriosis symptoms, norethindrone acetate and elagolix, affect brain health. Researchers will measure blood flow in the brain and markers of inflammation in 45 women with endometriosis. Participants will be randomly assigned to one of the two drugs. The goal is to see if these treatments have any effect on the brain's blood vessels or immune activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
norethindrone acetate and elagolix (Orlissa), two hormone-based medications approved for endometriosis symptoms
What this could lead to
If it works, this could help doctors choose endometriosis treatments that ease symptoms without harming brain health.
What could go wrong
This is a small, early-stage trial with only 45 participants, so results may not apply to everyone. The medications may affect brain blood flow or inflammation in ways that are hard to measure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female sex assigned at birth; * Age 18-40 years; * Premenopausal status characterized by regular (i.e., 21-35 day cycles) menstrual cycles or a follicle stimulating hormone (FSH) \< 10 IU/L in patients with irregular menstrual cycles. * Body mass index \< 39 kg/m2. Exclusion Criteria: * Preexisting or active cardiac, renal, or hepatic disease or use of medications for these disorders: past or current history of these diseases or conditions may impact participant safety associated with the intervention or may confound the study of the effect of the interventions because these diseases also impair vascular function. * Current use or use of hormonal contraceptives within past 3 months. * Use of vascular-altering medications that interfere with measurements (e.g., anti-hypertensive medications, GLP-1s, acetazolamide, etc.,). * Diabetic or fasted glucose ≥126 mg/dL: diabetes impairs vascular function and could influence interpretation of the data. * Current or recent (\<6 months) tobacco or nicotine use. * Pregnant, planning to become pregnant or breastfeeding within the past 3 months. * Known contraindications to MRI such as metal shavings or fragments in the head, eyes or neck. * Rested seated blood pressure \>140/90 mmHg; hypertension impairs cerebrovascular function and could influence the interpretation of data. * Use of vitamins, supplements or minerals or anti-inflammatory medications or unwillingness to stop for 7 days prior to MRI testing. * Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \>1.3mg/dL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Individuals with TSH levels outside of the normal range (0.5-5.0 mIU/mL) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \> 2 months; * Current medical insurance; for safety. Additional drug related exclusion criteria: We will additionally exclude for the following reasons as related to safety or contraindications for study medications: * Known hypersensitivity to study medications. * Suicidal ideation or suicidal behavior as evaluated using the C-SSRS * Use of medications contraindicated for the study medications (e.g., organic anion transporting polypeptide (OATP) 1B1, CYP3A inhibitors, or rifampin. * Total cholesterol \> 220 mg/dL at screening. * History of venous thromboembolic events (VTE), known inherited or acquired hypercoagulopathies; thrombogenic valvular or thrombogenic rhythm diseases of the heart (e.g., atrial fibrillation). * History of breast cancer or other estrogen-dependent neoplasm. * Osteoporosis defined as bone mineral density T-score ≤ -2.0. * Headaches with focal neurological symptoms or have migraine headaches with aura if over the age of 35 years. * Undiagnosed uterine bleeding.

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Conditions

The condition(s) this trial relates to.

disease Dysmenorrhea endometriosis Neuroinflammatory Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

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