EndometriosisPhase 4BLOOMNCT07799246
Brain and Blood Vessel Health Following Endometriosis Treatment in People With Endometriosis
A Phase 4 study testing Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health, Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health and Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health in people with Endometriosis and Endometriosis and Dysmenorrhea, run by Colorado State University.
Trial summary
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis and Dysmenorrhea, Endometriosis (Diagnosis)
- What is being tested?
- Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health, Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health and Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2029
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: BLOOM Study: Investigation of Endometriosis Treatments on Brain and Cerebrovascular Health
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.
Read the detailed description
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis. To learn about this, eligible participants with endometriosis will undergo a baseline blood draw and magnetic resonance imaging (MRI) scan. Then, they will be randomly assigned to receive one of three medications. The three medications used in this study are common medications that patients may receive to manage their symptoms of endometriosis. This means that they are medically approved for the treatment of endometriosis symptoms. Participants will complete the blood draw and MRI scan again after ~28 days of treatment.
- Being tested
- Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health, Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health, Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
- Keywords
- Endometriosis, Orlissa, Norethindrone acetate, Oriahnn, Cerebrovascular function, Neuroinflammation
- Medical subject headings
- Endometriosis, Dysmenorrhea, Disease, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthDrug
Also called norethindrone acetate
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthDrug
Also called Orlissa
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthDrug
Also called Oriahnn
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Norethindrone acetate | Active comparator | 5 mg norethindrone acetate pill, taken daily for ~28 days, approved to treat symptoms of endometriosis. Receives: Drug: Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health |
| Orlissa | Active comparator | Oral gonadotropin releasing antagonist, taken daily for ~28 days, approved for the treatment of moderate-to-severe endometriosis symptoms Receives: Drug: Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health |
| Oriahnn | Active comparator | Oral gonadotropin releasing antagonist, taken daily for ~28 days, with estrogen and progestin add-back. Receives: Drug: Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging
Measured: Baseline and ~28 days
Secondary outcomes (1)
Neuroinflammation
Plasma biomarker of astrocyte activation and neuroinflammation via glial fibrillary acidic protein [GFAP]
Measured: Baseline and ~28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly prospectively assigned to one of three treatments using a 1:1:1 design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Lyndsey DuBose, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799246
- Sponsor's protocol ID
- COMIRB 26-1596
- Other IDs
- 26CDA1591111, COMIRB 26-1596
- Acronym
- BLOOM
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOOM Study: Investigation of Endometriosis Treatments on Brain and Cerebrovascular Health
- ClinicalTrials.gov ID
- NCT07799246
- Acronym / sponsor ID
- BLOOM / COMIRB 26-1596
- Keywords
- Endometriosis, Orlissa, Norethindrone acetate, Oriahnn, Cerebrovascular function, Neuroinflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Sep 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 research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.
Detailed description
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis. To learn about this, eligible participants with endometriosis will undergo a baseline blood draw and magnetic resonance imaging (MRI) scan. Then, they will be randomly assigned to receive one of three medications. The three medications used in this study are common medications that patients may receive to manage their symptoms of endometriosis. This means that they are medically approved for the treatment of endometriosis symptoms. Participants will complete the blood draw and MRI scan again after ~28 days of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly prospectively assigned to one of three treatments using a 1:1:1 design.
| Arm | Type | Receives |
|---|---|---|
| Norethindrone acetate | Active comparator | Drug: Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health5 mg norethindrone acetate pill, taken daily for ~28 days, approved to treat symptoms of endometriosis. |
| Orlissa | Active comparator | Drug: Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthOral gonadotropin releasing antagonist, taken daily for ~28 days, approved for the treatment of moderate-to-severe endometriosis symptoms |
| Oriahnn | Active comparator | Drug: Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthOral gonadotropin releasing antagonist, taken daily for ~28 days, with estrogen and progestin add-back. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthAlso: norethindrone acetateEligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms. | Drug | Norethindrone acetate |
| Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthAlso: OrlissaEligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms. | Drug | Orlissa |
| Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain healthAlso: OriahnnEligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms. | Drug | Oriahnn |
Primary outcome
Cerebral blood flow
Time frame: Baseline and ~28 days
Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging
1 secondary outcome
Neuroinflammation
Time frame: Baseline and ~28-days
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
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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.
Lyndsey DuBose, PhD principal investigator
Colorado State University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health, Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health and Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health in people with Endometriosis and Endometriosis and Dysmenorrhea, run by Colorado State University.
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 21 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Lyndsey DuBose, PhD ((970) 491-5243, lyndsey.dubose@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: Baseline and ~28 days). 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 2 Sep 2026.