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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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22 April 2013 |
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Main ID: |
NCT00392756 |
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Date of registration:
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25/10/2006 |
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Primary sponsor: |
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Public title:
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Examination of Idiopathic Hypogonadotropic Hypogonadism (IHH)and Kallmann Syndrome (KS)
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Scientific title:
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Role of Gonadotropin Pulsations in the Reversal of Hypogonadotropic Hypogonadism |
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Date of first enrolment:
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April 1989 |
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Target sample size:
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800 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00392756 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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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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Ravikumar Balasumbramanian, MD, PhD |
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Address:
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Telephone:
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617-726-8432 |
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Email:
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RBALASUBRAMANIAN@PARTNERS.ORG |
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Affiliation:
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Name:
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Ravikumar Balasubramanian, MD, PhD |
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Address:
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Telephone:
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617-726-8432 |
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Email:
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RBALASUBRAMANIAN@PARTNERS.ORG |
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Affiliation:
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Name:
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William F Crowley, Jr., 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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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Eligibility
Ages Eligible for Study:
- Adolescent boys (16-17yrs)
- Adults (18 years and older)
- Genders Eligible for Study:
- Male and Female
- Accepts Healthy Volunteers:
- No
Criteria
Inclusion Criteria:
- adolescent boys (age 16-17 years) and adult male individuals (age 18 years and older)
with a single serum sample demonstrating low testosterone in association with low or
inappropriately normal gonadotropin levels
- suitable male and adult female hypogonadotropic hypogonadal subjects
Exclusion Criteria:
- no specific exclusion criteria
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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GnRH Deficiency
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Hypogonadotropic Hypogonadism
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Kallmann Syndrome
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Intervention(s)
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Drug: gonadotropin releasing hormone (GnRH)
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Primary Outcome(s)
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endogenous LH secretion pattern
[Time Frame: 8 to 24 hours]
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Secondary Outcome(s)
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sperm count
[Time Frame: up to 2 years]
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testicular volume
[Time Frame: up to 2 years]
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Secondary ID(s)
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5U54 HD028138
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U54HD028138-024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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