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Sex Hormones and Orthostatic Tolerance

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01153581
First received: June 28, 2010
Last updated: December 1, 2016
Last verified: December 2016

June 28, 2010
December 1, 2016
February 2006
December 2012   (Final data collection date for primary outcome measure)
  • Orthostatic Tolerance [ Time Frame: 2 months ]
    We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.
  • Baroreceptor Function [ Time Frame: 2 months ]

    This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.

    Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg.

  • Skin Microvascular Responses [ Time Frame: 2 months ]
    Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as "% max." This is measured with a Laser Doppler probes, which measures volts.
  • Orthostatic Tolerance [ Time Frame: 4 years ]
  • Baroreceptor Function [ Time Frame: 4 years ]
  • Skin Microvascular Responses [ Time Frame: 4 years ]
Complete list of historical versions of study NCT01153581 on ClinicalTrials.gov Archive Site
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Not Provided
 
Sex Hormones and Orthostatic Tolerance
Sex Hormones and Orthostatic Tolerance
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Orthostatic Intolerance
  • Drug: Ganirelix acetate
    Ganirelix acetate: .25 ml/day by subcutaneous injection
    Other Name: Antagon
  • Drug: 17β-Oestradiol
    17 beta estradiol: 0.2 mg/day (patches)
    Other Names:
    • 17 beta estradiol
    • estradiol
  • Drug: Progesterone
    progesterone, 200 mg day−1 oral
    Other Names:
    • P4
    • Prometrium
  • Experimental: Ganirelix acetate
    Subjects were given 250 μg in 0.5ml normal saline for 16 days. (Organon, Roseland, NJ, USA)
    Intervention: Drug: Ganirelix acetate
  • Experimental: 17β-Oestradiol, E2
    The same women added 17β-Oestradiol, E2; 0.2 mg day−1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
    Intervention: Drug: 17β-Oestradiol
  • Experimental: Progesterone
    The same women added progesterone (P4, 200 mg day−1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.
    Intervention: Drug: Progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
May 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 34 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01153581
0512000875a, 2R01HL071159-04
No
Not Provided
Yes
Our data are stored in locked files, and our spreadsheets and raw data are available should they be requested
Yale University
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Nina Stachenfeld, PhD Yale University
Yale University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP