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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
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Growth Disorders focused on measuring constitutional growth delay, endocrine disorders, rare disease

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Short stature and/or constitutional growth delay No epilepsy or risk of epilepsy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of Michigan
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    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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