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...
Date First Received: February 24, 2000
Last Updated: June 23, 2005
Verified by: Office of Rare Diseases (ORD), December 2001
Clinical Trial Phase: N/A | Start Date: June 1995
Overall Status: Completed
Estimated Enrollment: 4
Brief Summary
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Screening
Detailed Clinical Trial 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.
Criteria for Participation in this Clinical Trial
- Short stature and/or constitutional growth delay
- No epilepsy or risk of epilepsy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Center for Research Resources (NCRR)
Overall Clinical Trial Officials and Contacts
Carol M. Foster Study Chair University of Michigan
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004793
Study ID Number: 199/11923
ClinicalTrials.gov Identifier: NCT00004793
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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