Leuprolide in Determining the Cause of Gonadotropin Deficiency - Full Text View

Leuprolide in Determining the Cause of Gonadotropin Deficiency

This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, January 2000

Sponsors and Collaborators:	FDA Office of Orphan Products Development University of Chicago
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004426

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

Drug Information available for:

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

FDA Office of Orphan Products Development

University of Chicago

Investigators


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

Endocrine System Diseases

Endocrinopathy

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Fertility Agents, Female

Physiological Effects of Drugs

Fertility Agents

Reproductive Control Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008