Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
Primary Purpose
Growth Disorders
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Growth Disorders focused on measuring constitutional growth delay, endocrine disorders, rare disease
Eligibility Criteria
Short stature and/or constitutional growth delay No epilepsy or risk of epilepsy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004793
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00004793
Brief Title
Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
Study Type
Observational
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
June 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorders
Keywords
constitutional growth delay, endocrine disorders, rare disease
7. Study Design
Enrollment
4 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Short stature and/or constitutional growth delay
No epilepsy or risk of epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol M. Foster
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
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