Completed

Testis-Stimulating Factor Purification in Precocious Puberty

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What is being collected

Drug Data

+ drug Data

Drug
Who is being recruted

Gonadal Disorders+4

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

Over 18 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: January 1997
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00004344
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Gonadal DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesEndocrine System DiseasesPuberty, PrecociousRare Diseases

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers