Sex Hormones and Orthostatic Tolerance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina Stachenfeld, Yale University
ClinicalTrials.gov Identifier:
NCT01153581
First received: June 28, 2010
Last updated: January 14, 2014
Last verified: January 2014
  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 ]

Enrollment: 62
Study Start Date: February 2006
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Estrogen and Progesterone
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153581

Locations
United States, Connecticut
John B. Pierce Laboratory
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nina Stachenfeld, PhD Yale University
  More Information

No publications provided

Responsible Party: Nina Stachenfeld, Associate Professor, Yale University
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: January 14, 2014
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
Progesterone
Ganirelix
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
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 October 01, 2014