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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00004793

First Posted: February 25, 2000

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University of Michigan

Information provided by:

Office of Rare Diseases (ORD)

Tracking Information

First Submitted Date

February 24, 2000

First Posted Date

February 25, 2000

Last Update Posted Date

December 9, 2005

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

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

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

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