Expired Study
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New Haven, Connecticut 06519


Purpose:

This study is designed to determine the causes of "orthostatic intolerance" which occurs more commonly in women than in men. Orthostatic tolerance is the ability to remain standing up right for long periods of time, or to avoid dizziness when moving to standing from a seated or lying position.


Study summary:

In this study we are interested in determining the impact of female reproductive hormones (estrogen and progesterone) on orthostatic tolerance (described above) so we administer these hormones to participants. We also test participants' orthostatic tolerance in our laboratory and use this information to place subjects into groups.


Criteria:

Inclusion Criteria: - Healthy, English-speaking non-smoking women age 18- 34 with regular menses Exclusion Criteria: - Gynecologic: 1. current or past estrogen-dependent neoplasia, 2. unexplained vaginal bleeding, 3. history of uterine fibroids, 4. current pregnancy, 5. known or suspected breast or uterine cancer, 6. partial or complete hysterectomy - Cardiac: 1. myocardial infarction, ventricle tachycardia or fibrillation, 2. angina, 3. valvular disease, 4. congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea, 5. current arrhythmias, 6. prosthetic valves - Pulmonary: 1. current cigarette smokers, or pipe or cigar smokers, 2. chronic obstructive pulmonary disease, 3. adult asthma, 4. dyspnea on exertion, 5. current bronchitis, pneumonia, or tuberculosis, 6. lung carcinoma, 7. pulmonary embolus, recent - Vascular: 1. claudication or history of peripheral vascular disease, 2. abdominal or thoracic aortic aneurysm, or repair of same, 3. cerebral aneurysm, vascular malformations, 4. hypertension, systolic or diastolic, or strong family history of hypertension - Gastrointestinal: 1. GI malignancy, 2. hepatitis, current, 3. splenomegaly from any cause, 4. Cholecystitis, 5. current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's Disease, 6. previous gastrointestinal surgery - Infectious Disease: any intercurrent infection - Hematologic/Oncologic: 1. receiving chemotherapy or radiation therapy, 2. any metastatic malignancy, 3. anemia (hematocrit < 35), 4. thrombocytopenia or thrombocytosis, 5. neutropenia, 6. hematologic malignancy, 7. bleeding dyscrasia - Neurologic: 1. history of cerebral vascular accident with any neurologic sequels, 2. uncontrolled seizures (e.g. more than 1 seizure/year), 3. transient ischemic attacks, 4. dementia, 5. neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy, 6. severe migraine headaches - Endocrine: 1. diabetes mellitus, 2. any untreated endocrinopathy - Renal: 1. chronic renal disease, 2. any history of renal disease or impairment, 3. current urinary tract infection - Musculoskeletal: 1. inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters), 2. any history of pathologic fractures, including vertebral compression fractures - Pharmacologic: 1. any illegal drug use, 2. alcohol use greater than an average of 4 oz/day over 30 days, 3. coumadin or heparin use, 4. current systemic antifungal use


NCT ID:

NCT01153581


Primary Contact:

Principal Investigator
Nina Stachenfeld, PhD
Yale University


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06519
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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