Sex Hormones and Orthostatic Tolerance

This study is currently recruiting participants.
Verified August 2011 by Yale University
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01153581
First received: June 28, 2010
Last updated: August 5, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: 17 beta estradiol, progesterone, ganirelix acetate
    Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills
    Other Name: Antagon for ganirelix acetate
    Drug: 17 beta estradiol, progesterone, ganirelix acetate
    17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day
    Other Name: ganirelix acetate Antagon
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

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153581

Contacts
Contact: Nina Stachenfeld, PhD 203-562-9901 ext 219 nstach@jbpierce.org
Contact: Cheryl Leone, MA 203-562-9901 ext 266 cleone@jbpierce.org

Locations
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            
Sponsors and Collaborators
Yale University
Investigators
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