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NCT00004344 Clinical Trial

Purification of Testis-Stimulating Factor in Precocious Puberty

Precocious Puberty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004344
Other study ID # 199/11903
Secondary ID OHSU-3328
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date January 1997

Study information
Verified date February 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility PROTOCOL ENTRY CRITERIA:

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• leuprolide

• testosterone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Oregon Health and Science University
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