Brain and Blood Vessel Health Following Endometriosis Treatment in People With Endometriosis
BLOOM
BLOOM Study: Investigation of Endometriosis Treatments on Brain and Cerebrovascular Health
2 other identifiers
interventional
45
0 countries
N/A
Brief Summary
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2026
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2026
CompletedFirst Posted
Study publicly available on registry
September 2, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
September 2, 2026
August 1, 2026
2.6 years
August 10, 2026
August 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cerebral blood flow
Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging
Baseline and ~28 days
Secondary Outcomes (1)
Neuroinflammation
Baseline and ~28-days
Other Outcomes (1)
Neuronal microstructure
Baseline and ~28 days
Study Arms (3)
Norethindrone acetate
ACTIVE COMPARATOR5 mg norethindrone acetate pill, taken daily for \~28 days, approved to treat symptoms of endometriosis.
Orlissa
ACTIVE COMPARATOROral gonadotropin releasing antagonist, taken daily for \~28 days, approved for the treatment of moderate-to-severe endometriosis symptoms
Oriahnn
ACTIVE COMPARATOROral gonadotropin releasing antagonist, taken daily for \~28 days, with estrogen and progestin add-back.
Interventions
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colorado State Universitylead
- University of Colorado, Denvercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lyndsey DuBose, PhD
Colorado State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2026
First Posted
September 2, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
September 2, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share