Purification of Testis-Stimulating Factor in Precocious Puberty

This study has been completed.

Sponsor:

Collaborator:

Oregon Health and Science University

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004344

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: February 2000

History of Changes

Purpose

OBJECTIVES:

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

Condition	Intervention
Precocious Puberty	Drug: leuprolide Drug: testosterone

Study Type:	Observational
Study Design:	Primary Purpose: Screening

Resource links provided by NLM:

Genetics Home Reference related topics: familial male-limited precocious puberty

MedlinePlus related topics: Endocrine Diseases Puberty Testicular Disorders

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	4
Study Start Date:	January 1997

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00004344 History of Changes
Other Study ID Numbers:	199/11903, OHSU-3328
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

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
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Androgens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013

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