Purpose

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.


Condition Intervention
Hypogonadism
Drug: gonadotropin releasing hormone
Drug: leuprolide

Genetics Home Reference related topics:   Endocrine Diseases  

ChemIDplus related topics:   Leuprolide acetate   Leuprolide   Gonadorelin   Gonadorelin hydrochloride   LH-RH  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Efficacy Study
Official Title:   Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:   90
Study Start Date:   December 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004426

Locations
United States, Illinois
University of Chicago Children's Hospital     Recruiting
      Chicago, Illinois, United States, 60637
      Contact: Robert L. Rosenfield     773-702-6432        

Sponsors and Collaborators

Investigators
Study Chair:     Robert L. Rosenfield     University of Chicago    
United States, Illinois
University of Chicago Children's Hospital     Recruiting
      Chicago, Illinois, United States, 60637
      Contact: Robert L. Rosenfield     773-702-6432        
FDA Office of Orphan Products Development
University of Chicago
Study Chair:     Robert L. Rosenfield     University of Chicago    
  More Information

Study ID Numbers:   199/13361, UCCH-FDR001012
First Received:   October 18, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004426
Health Authority:   United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
endocrine disorders  
hypogonadism  
rare disease  

Study placed in the following topic categories:
Hypogonadism
Leuprolide
Gonadal Disorders
Rare Diseases
Endocrinopathy

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Physiological Effects of Drugs
Fertility Agents
Endocrine System Diseases
Reproductive Control Agents
Pharmacologic Actions
Hypogonadism

Source: National Library of Medicine (NLM) July 03, 2008