Status:
COMPLETED
Sex Hormones and Orthostatic Tolerance
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Orthostatic Intolerance
Eligibility:
FEMALE
18-34 years
Phase:
PHASE2
Brief Summary
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 p...
Detailed Description
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 part...
Eligibility Criteria
Inclusion
- Healthy, English-speaking non-smoking women age 18- 34 with regular menses
Exclusion
- Gynecologic:
- current or past estrogen-dependent neoplasia,
- unexplained vaginal bleeding,
- history of uterine fibroids,
- current pregnancy,
- known or suspected breast or uterine cancer,
- partial or complete hysterectomy
- Cardiac:
- myocardial infarction, ventricle tachycardia or fibrillation,
- angina,
- valvular disease,
- congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea,
- current arrhythmias,
- prosthetic valves
- Pulmonary:
- current cigarette smokers, or pipe or cigar smokers,
- chronic obstructive pulmonary disease,
- adult asthma,
- dyspnea on exertion,
- current bronchitis, pneumonia, or tuberculosis,
- lung carcinoma,
- pulmonary embolus, recent
- Vascular:
- claudication or history of peripheral vascular disease,
- abdominal or thoracic aortic aneurysm, or repair of same,
- cerebral aneurysm, vascular malformations,
- hypertension, systolic or diastolic, or strong family history of hypertension
- Gastrointestinal:
- GI malignancy,
- hepatitis, current,
- splenomegaly from any cause,
- Cholecystitis,
- current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's Disease,
- previous gastrointestinal surgery
- Infectious Disease: any intercurrent infection
- Hematologic/Oncologic:
- receiving chemotherapy or radiation therapy,
- any metastatic malignancy,
- anemia (hematocrit \< 35),
- thrombocytopenia or thrombocytosis,
- neutropenia,
- hematologic malignancy,
- bleeding dyscrasia
- Neurologic:
- history of cerebral vascular accident with any neurologic sequels,
- uncontrolled seizures (e.g. more than 1 seizure/year),
- transient ischemic attacks,
- dementia,
- neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy,
- severe migraine headaches
- Endocrine:
- diabetes mellitus,
- any untreated endocrinopathy
- Renal:
- chronic renal disease,
- any history of renal disease or impairment,
- current urinary tract infection
- Musculoskeletal:
- inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters),
- any history of pathologic fractures, including vertebral compression fractures
- Pharmacologic:
- any illegal drug use,
- alcohol use greater than an average of 4 oz/day over 30 days,
- coumadin or heparin use,
- current systemic antifungal use
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01153581
Start Date
February 1 2006
End Date
May 1 2013
Last Update
December 13 2018
Active Locations (1)
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1
John B. Pierce Laboratory
New Haven, Connecticut, United States, 06519