Leuprolide in Determining the Cause of Gonadotropin Deficiency

Hypogonadism Clinical Trial

Official title:

Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004426
• Other study ID #: 199/13361
• Secondary ID: UCCH-FDR001012
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 25, 2015
• Start date: August 1994
• Est. completion date: September 1998

Study information

• Verified date: January 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• gonadotropin releasing hormone

• leuprolide

Locations

Country	Name	City	State
United States	University of Chicago Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States,