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
  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:


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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004344

Sponsors and Collaborators
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 August 28, 2014