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NCT00004793 Clinical Trial

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

Growth Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004793
Other study ID # 199/11923
Secondary ID UMMC-1354
Status Completed
Phase N/A
First received February 24, 2000
Last updated June 23, 2005
Start date June 1995

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility - Short stature and/or constitutional growth delay

- No epilepsy or risk of epilepsy

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Michigan
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