Purification of Testis-Stimulating Factor in Precocious Puberty

National Center for Research Resources (NCRR)

Status: Completed

Conditions: Precocious Puberty

Treatments: Drug: testosterone; Drug: leuprolide

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00004344

199/11903

OHSU-3328

Details and patient eligibility

About

OBJECTIVES:

Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

Adult men diagnosed with precocious puberty (familial testotoxicosis) as boys