Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Michigan
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004793

Purpose

OBJECTIVES: I. Evaluate the effect of bromocriptine on luteinizing hormone (LH) secretion by suppression of prolactin and stimulation of dopaminergic receptors in early pubertal boys and girls. II. Evaluate the effect of baclofen on LH secretion by stimulation of gamma-aminobutyric acid receptors in early pubertal boys and girls.

Condition
Growth Disorders

MedlinePlus related topics: Growth Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	4
Study Start Date:	June 1995

Detailed Description:

PROTOCOL OUTLINE:

Participants receive bromocriptine or baclofen followed by nocturnal measurements of luteinizing hormone, growth hormone, and sex steroids. Pituitary reserve is evaluated with the administration of gonadotropin-releasing hormone, and in children undergoing assessment of short stature, standard provocative stimuli.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Short stature and/or constitutional growth delay
No epilepsy or risk of epilepsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004793

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Michigan

Investigators

Study Chair:

Carol M. Foster

University of Michigan

More Information

No publications provided

Study ID Numbers:	199/11923, UMMC-1354
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004793 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

constitutional growth delay
endocrine disorders
rare disease

Study placed in the following topic categories:

Bromocriptine
Baclofen
Growth Disorders
Rare Diseases

Endocrine System Diseases
Endocrinopathy
Hormones

Additional relevant MeSH terms:

Pathologic Processes
Growth Disorders

ClinicalTrials.gov processed this record on May 07, 2009