Leuprolide in Determining the Cause of Gonadotropin Deficiency

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, January 2000

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Leuprolide Leuprolide acetate LH-RH

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	199/13361, UCCH-FDR001012
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004426 History of Changes
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
Antineoplastic Agents, Hormonal
Leuprolide
Gonadal Disorders
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Rare Diseases
Endocrine System Diseases
Endocrinopathy
Hormones

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Reproductive Control Agents

Hormones
Pharmacologic Actions
Hypogonadism
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on July 02, 2009