Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
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ClinicalTrials.gov Identifier: NCT00004793 |
Recruitment Status
:
Completed
First Posted
: February 25, 2000
Last Update Posted
: June 24, 2005
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Tracking Information | ||||
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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. |
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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. |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Enrollment |
4 | |||
Original Enrollment | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria |
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Sex/Gender |
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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 |
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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 |
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PRS Account | Office of Rare Diseases (ORD) | |||
Verification Date | December 2001 |