Clinical trial NCT01153581: Sex Hormones and Orthostatic Tolerance
Official title: Sex Hormones and Orthostatic Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orthostatic Intolerance
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-06-30
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 periods of time, or to avoid dizziness when moving to standing from a seated or lying position.

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 participants. We also test participants' orthostatic tolerance in our laboratory and use this information to place subjects into groups.

Eligibility 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

Primary outcomes:
measure: Orthostatic Tolerance
timeFrame: 2 months
measure: Baroreceptor Function
timeFrame: 2 months
measure: Skin Microvascular Responses
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: John B. Pierce Laboratory
state: Connecticut
Study officials:
affiliation: Yale University
name: Nina Stachenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References: