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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00434915 |
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Date of registration:
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12/02/2007 |
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Primary sponsor: |
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Public title:
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Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
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Scientific title:
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Does DHEA Enhance the Effects of Exercise in Postmenopausal Women? |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00434915 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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K. Sreekumaran Nair, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects will be postmenopausal women between the ages of 60 and 75 years old.
- Women with levels of DHEA less than 110 mg will be selected.
Exclusion Criteria:
- Individuals with history or biochemical evidence of liver disease, cardiovascular
disease (other than controlled hypertension); polycythemia, cerebrovascular
disorders, or disorder of glucose metabolism with fasting hyperglycemia or
hypoglycemia will be excluded.
- Use of psycotropic drugs within six months prior to enrollment
- History of severe depression or psychotic disorder
- Professional athletes or BMI greater than 30kg/m2
- Anyone who has been in a regular (greater than twice/weekly) exercise program for
more than 2 months prior to the study
- Severe rheumatologic condition with chronic pain not well controlled.
- Use of DHEA, estrogen, progesterone, testosterone, corticosteroid products up to six
months prior to study
Age minimum:
55 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Aging
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Intervention(s)
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Drug: DHEA
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Primary Outcome(s)
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body composition
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glucose and insulin metabolism
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muscle protein synthesis
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physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
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quality of life
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Secondary ID(s)
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2010-02
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P01 AG-14383
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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