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

June 28, 2010
January 14, 2014
February 2006
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01153581 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Orthostatic Intolerance
  • 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
Experimental: 1
Estrogen and Progesterone
Interventions:
  • Drug: 17 beta estradiol, progesterone, ganirelix acetate
  • Drug: 17 beta estradiol, progesterone, ganirelix acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
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
Female
18 Years to 34 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01153581
0512000875a, 2 R01 HL 071159-04
No
Nina Stachenfeld, Yale University
Yale University
Not Provided
Principal Investigator: Nina Stachenfeld, PhD Yale University
Yale University
January 2014

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