BLOOM Study: Investigation of Endometriosis Treatments on Brain and Cerebrovascular Health
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Cerebral blood flow
研究概览
简要总结
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 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.
- •Headaches with focal neurological symptoms or have migraine headaches with aura if over the age of 35 years.
- •Undiagnosed uterine bleeding.
研究组 & 干预措施
Norethindrone acetate
5 mg norethindrone acetate pill, taken daily for ~28 days, approved to treat symptoms of endometriosis.
干预措施: Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health (Drug)
Orlissa
Oral gonadotropin releasing antagonist, taken daily for ~28 days, approved for the treatment of moderate-to-severe endometriosis symptoms
干预措施: Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health (Drug)
Oriahnn
Oral gonadotropin releasing antagonist, taken daily for ~28 days, with estrogen and progestin add-back.
干预措施: Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health (Drug)
结局指标
主要结局
Cerebral blood flow
时间窗: Baseline and ~28 days
Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging
次要结局
- Neuroinflammation(Baseline and ~28-days)