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Purification of Testis-Stimulating Factor in Precocious Puberty

Primary Purpose

Precocious Puberty

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
leuprolide
testosterone
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Precocious Puberty focused on measuring endocrine disorders, precocious puberty, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: Adult men diagnosed with precocious puberty (familial testotoxicosis) as boys

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004344
    Brief Title
    Purification of Testis-Stimulating Factor in Precocious Puberty
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1997 (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
    Oregon Health and Science University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.
    Detailed Description
    PROTOCOL OUTLINE: Subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks. Hormone levels are tested every other week. If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56, blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization. Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Precocious Puberty
    Keywords
    endocrine disorders, precocious puberty, rare disease

    7. Study Design

    Enrollment
    4 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    leuprolide
    Intervention Type
    Drug
    Intervention Name(s)
    testosterone

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: Adult men diagnosed with precocious puberty (familial testotoxicosis) as boys
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barry Albertson
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Purification of Testis-Stimulating Factor in Precocious Puberty

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