Can common endometriosis drugs change blood flow in the brain?
NCT ID NCT07799246
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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