Sex Hormones and Orthostatic Tolerance
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Orthostatic Intolerance |
Drug: 17 beta estradiol, progesterone, ganirelix acetate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Sex Hormones and Orthostatic Tolerance |
- orthostatic tolerance [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- baroreceptor function [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- skin microvascular responses [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Drug: 17 beta estradiol, progesterone, ganirelix acetate
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| Ages Eligible for Study: | 18 Years to 34 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy, English-speaking non-smoking women age 18- 34 with regular menses
Exclusion Criteria:
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
Contacts and Locations| Contact: Nina Stachenfeld, PhD | 203-562-9901 ext 219 | nstach@jbpierce.org |
| Contact: Cheryl Leone, MA | 203-562-9901 ext 266 | cleone@jbpierce.org |
| United States, Connecticut | |
| John B. Pierce Laboratory | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Nina Stachenfeld, PhD 203-562-9901 ext 219 nstach@jbpierce.org | |
| Contact: Cheryl Leone, MA 203-562-9901 ext 266 cleone@jbpierce.org | |
| Principal Investigator: Nina Stachenfeld, PhD | |
| Principal Investigator: | Nina Stachenfeld, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Nina Stachenfeld, PhD, John B. Pierce Laboratory, Inc. |
| ClinicalTrials.gov Identifier: | NCT01153581 History of Changes |
| Other Study ID Numbers: | 0512000875a, 2 R01 HL 071159-04 |
| Study First Received: | June 28, 2010 |
| Last Updated: | August 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Orthostatic Intolerance Mitral Valve Prolapse Neurocirculatory Asthenia Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Heart Valve Prolapse Heart Valve Diseases Heart Diseases Cardiovascular Diseases Anxiety Disorders Mental Disorders Estradiol |
Polyestradiol phosphate Hormones Progesterone Ganirelix Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 16, 2013