Brain and Blood Vessel Health Following Endometriosis Treatment in People With Endometriosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorColorado State University
About this trial
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
DrugEligible 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 health
DrugEligible 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 health
DrugEligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Norethindrone acetateActive comparator 1 intervention
Group B: OrlissaActive comparator 1 intervention
Group C: OriahnnActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cerebral blood flow
Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging
Time frame
Baseline and ~28 daysSecondary outcomes
1
Neuroinflammation
Plasma biomarker of astrocyte activation and neuroinflammation via glial fibrillary acidic protein \[GFAP\]
Time frame
Baseline and ~28-daysOther outcomes
1
Neuronal microstructure
Grey and white matter neuronal microstructure
Time frame
Baseline and ~28 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: