Trials / Completed
CompletedNCT00004344
Purification of Testis-Stimulating Factor in Precocious Puberty
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | leuprolide | |
| DRUG | testosterone |
Timeline
- Start date
- 1997-01-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004344. Inclusion in this directory is not an endorsement.