Endometriosis, Endometriosis and Dysmenorrhea, Endometriosis (Diagnosis)
Conditions
Keywords
Endometriosis, Orlissa, Norethindrone acetate, Oriahnn, Cerebrovascular function, Neuroinflammation
Brief summary
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.
Interventions
DRUGInvestigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
DRUGInvestigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
DRUGInvestigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Sponsors
Colorado State University
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly prospectively assigned to one of three treatments using a 1:1:1 design.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral blood flow | Baseline and ~28 days | Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuroinflammation | Baseline and ~28-days | Plasma biomarker of astrocyte activation and neuroinflammation via glial fibrillary acidic protein \[GFAP\] |
Contacts
CONTACTLyndsey DuBose, PhD
CONTACTJulia Seifert
PRINCIPAL_INVESTIGATORLyndsey DuBose, PhD
Colorado State University
Outcome results
None listed