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

Status Completed

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.

Clinical Trial 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 ;

Study Design

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

Related Conditions & MeSH terms

• Hypogonadism

• NCT number: NCT00004426
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: N/A
• Start date: August 1994
• Completion date: September 1998