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NCT07799246Not yet recruitingPhase 4

Brain and Blood Vessel Health Following Endometriosis Treatment in People With Endometriosis

BLOOM Study: Investigation of Endometriosis Treatments on Brain and Cerebrovascular Health

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
45 (estimated)
First submitted
10 Aug 2026
Start date
1 Oct 2026
Primary completion date
30 Apr 2029
Lead sponsor
Colorado State University
NCT number
NCT07799246

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 45
  • From 1 Oct 2026 to the primary completion date, 30 Apr 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of vascular-altering medications that interfere with measurements (e.g., anti-hypertensive medications, GLP-1s, acetazolamide, etc.,).
  • Use of vitamins, supplements or minerals or anti-inflammatory medications or unwillingness to stop for 7 days prior to MRI testing.
  • 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:
  • Use of medications contraindicated for the study medications (e.g., organic anion transporting polypeptide (OATP) 1B1, CYP3A inhibitors, or rifampin.

Other illness

  • 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.
  • Rested seated blood pressure \>140/90 mmHg; hypertension impairs cerebrovascular function and could influence the interpretation of data.
  • Known hypersensitivity to study medications.
  • 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.
  • Undiagnosed uterine bleeding.

Lab values

  • Diabetic or fasted glucose ≥126 mg/dL: diabetes impairs vascular function and could influence interpretation of the data.
  • 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;
  • Total cholesterol \> 220 mg/dL at screening.

Age

  • Headaches with focal neurological symptoms or have migraine headaches with aura if over the age of 35 years.

Other

  • Current use or use of hormonal contraceptives within past 3 months.
  • 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.
  • Suicidal ideation or suicidal behavior as evaluated using the C-SSRS
  • Osteoporosis defined as bone mineral density T-score ≤ -2.0.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.