Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
This study has been completed.
Sponsor:
National Center for Research Resources (NCRR)
Collaborator:
University of Michigan
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004793
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
| Tracking Information | ||||
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| First Received Date ICMJE | February 24, 2000 | |||
| Last Updated Date | June 23, 2005 | |||
| Start Date ICMJE | June 1995 | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE | Not Provided | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children | |||
| Official Title ICMJE | 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 ICMJE | Observational | |||
| Study Design ICMJE | Primary Purpose: Screening | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Not Provided | |||
| Study Population | Not Provided | |||
| Condition ICMJE | Growth Disorders | |||
| Intervention ICMJE | Not Provided | |||
| Study Group/Cohort (s) | Not Provided | |||
| Publications * | Not Provided | |||
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* 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 ICMJE | Completed | |||
| Enrollment ICMJE | 4 | |||
| Completion Date | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE |
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| Gender | Both | |||
| Ages | up to 18 Years (Child, Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00004793 | |||
| Other Study ID Numbers ICMJE | 199/11923, UMMC-1354 | |||
| Has Data Monitoring Committee | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | |||
| Collaborators ICMJE | University of Michigan | |||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | |||
| Verification Date | December 2001 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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