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

Tracking Information
First Submitted Date	February 24, 2000
First Posted Date	February 25, 2000
Last Update Posted Date	June 24, 2005
Study Start Date	June 1995
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
Official Title	Not Provided
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.
Study Type	Observational
Study Design	Primary Purpose: Screening
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Growth Disorders
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Enrollment; (submitted: June 23, 2005)	4
Original Enrollment	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	Short stature and/or constitutional growth delay; No epilepsy or risk of epilepsy
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 18 Years (Child, Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT00004793
Other Study ID Numbers	199/11923; UMMC-1354
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	National Center for Research Resources (NCRR)
Collaborators	University of Michigan
Investigators	Study Chair: Carol M. Foster University of Michigan
PRS Account	Office of Rare Diseases (ORD)
Verification Date	December 2001