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Leuprolide in Determining the Cause of Gonadotropin Deficiency

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004426
First received: October 18, 1999
Last updated: March 25, 2015
Last verified: January 2000

October 18, 1999
March 25, 2015
August 1994
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Complete list of historical versions of study NCT00004426 on ClinicalTrials.gov Archive Site
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Leuprolide in Determining the Cause of Gonadotropin Deficiency
Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency

RATIONALE: The body's response to one injection of leuprolide may provide more information than the standard test for gonadotropin deficiency in determining whether the cause of gonadotropin deficiency is related to the hypothalamus or the pituitary gland.

PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in determining the cause of gonadotropin deficiency.

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive leuprolide acetate or gonadotropin releasing hormone (GnRH) first, then cross over to receive the other test.

Patients receive one subcutaneous injection of leuprolide acetate or GnRH, then have blood samples drawn periodically. One month later, patients receive the other test.

Another cohort of patients are randomized to receive leuprolide acetate once daily on days 0, 4, and 8, or days 0, 5, and 10.

Patients are followed for up to 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Hypogonadism
  • Drug: gonadotropin releasing hormone
  • Drug: leuprolide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 1998
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PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Prepubertal children with constitutionally delayed puberty At least 2 years retardation of bone age Spontaneously progress into puberty within 1 year Boys: Testes long diameter 2.5-3.5 cm and plasma testosterone 40-300 ng/dL Girls: Breast development, but premenarcheal OR Hypogonadotropinism Delayed onset of pubertal milestones associated with anterior panhypopituitarism OR Kallman's syndrome No spontaneous progression into puberty within 2 years after 6 months replacement sex steroid treatment

--Prior/Concurrent Therapy--

  • At least 2 months since prior sex hormone treatment

--Patient Characteristics--

  • Age: 14-18 for children with hypogonadotropinism 9-13 for normal children
  • Other: No chronic systemic disease No metabolic disease No endocrine disease No growth hormone deficiency
Both
9 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004426
199/13361, UCCH-FDR001012
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University of Chicago
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Study Chair: Robert L. Rosenfield University of Chicago
FDA Office of Orphan Products Development
January 2000

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