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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00324064 |
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Date of registration:
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08/05/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
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Scientific title:
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Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00324064 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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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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Jill Jacobson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Mercy Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Healthy subjects
- Males and females, Tanner stage V aged 15-40 years of age with no known endocrine
problems
- Males and females, Tanner stage I, aged 5-8 years with no known endocrine problems
GH subjects - Males and females, Tanner stage V, aged 15-21 years with a history of
childhood growth hormone deficiency
Exclusion Criteria:
Healthy subjects
- History of GH deficiency or treatment or other known endocrine disorder
- Current height or adult height <5th %
- Female subjects using hormonal methods of birth control
- Female subjects with irregular menstrual cycles
GH subjects
- Subjects with GH deficiency who have not discontinued GH treatment for at least 2 months
Age minimum:
5 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Procedure: GHRH/arginine stimulation testing
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Primary Outcome(s)
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Serum GH levels in response to GHRH/arginine stimulation
[Time Frame: End of study]
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Secondary Outcome(s)
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mRNA and protein levels of G alpha q and G alpha S stimulatory proteins
[Time Frame: end of study]
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Serum gonadal steroid levels in the three subject groups
[Time Frame: end of study]
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Secondary ID(s)
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06 03-053
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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