Purification of Testis-Stimulating Factor in Precocious Puberty

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00004344

Enrollment

Registered

1999-10-19

Start date

1997-01-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precocious Puberty

Keywords

endocrine disorders, precocious puberty, rare disease

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.

Interventions

DRUGleuprolide

DRUGtestosterone

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026