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Leuprolide in Determining the Cause of Gonadotropin Deficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004426
First Posted: October 19, 1999
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
  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: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency

Resource links provided by NLM:


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

Estimated Enrollment: 90
Study Start Date: August 1994
Estimated Study Completion Date: September 1998
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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004426


Locations
United States, Illinois
University of Chicago Children's Hospital
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Robert L. Rosenfield University of Chicago
  More Information

ClinicalTrials.gov Identifier: NCT00004426     History of Changes
Other Study ID Numbers: 199/13361
UCCH-FDR001012
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: March 26, 2015
Last Verified: January 2000

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

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Hormones
Leuprolide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents