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

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

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