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Purification of Testis-Stimulating Factor in Precocious Puberty

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ClinicalTrials.gov Identifier: NCT00004344
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

OBJECTIVES:

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


Condition or disease Intervention/treatment
Precocious Puberty Drug: leuprolide Drug: testosterone

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.


Study Design

Study Type : Observational
Estimated Enrollment : 4 participants
Primary Purpose: Screening
Study Start Date : January 1997


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004344


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Oregon Health and Science University
Investigators
Study Chair: Barry Albertson Oregon Health and Science University
More Information

ClinicalTrials.gov Identifier: NCT00004344     History of Changes
Other Study ID Numbers: 199/11903
OHSU-3328
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2000

Keywords provided by Office of Rare Diseases (ORD):
endocrine disorders
precocious puberty
rare disease

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Testosterone
Leuprolide
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents