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Trial record 6 of 12 for:    "Precocious Puberty" | "Hormone Antagonists"

Purification of Testis-Stimulating Factor in Precocious Puberty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004344
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Oregon Health and Science University
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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.

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

Information from the National Library of Medicine

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


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

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 identifier (NCT number): NCT00004344

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

Layout table for additonal information Identifier: NCT00004344     History of Changes
Other Study ID Numbers: 199/11903
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:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents