Clinical Trials Logo
  1. Home
  2. Precocious Puberty
  3. NCT00004344
  4. Details
NCT00004344 Clinical Trial

Purification of Testis-Stimulating Factor in Precocious Puberty

Precocious Puberty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004344
Other study ID # 199/11903
Secondary ID OHSU-3328
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date January 1997

Study information
Verified date February 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility PROTOCOL ENTRY CRITERIA:

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• leuprolide

• testosterone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Oregon Health and Science University
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01944475 - Follow-up of Girls With Premature Thelarche and Precocious Puberty N/A
Not yet recruiting NCT01944488 - LH Response to GnRH Test in Prepubescent Girls Under 6 Years N/A
Completed NCT00564850 - Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty Phase 3
Completed NCT00001181 - Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty Phase 2
Recruiting NCT04113070 - Overweight and Obesity and Puberty Development Cohort Study
Recruiting NCT01601171 - Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
Completed NCT00734279 - Follicle-Stimulating Hormone (FSH) and the Onset of Puberty Early Phase 1
Recruiting NCT05338411 - Effect of Exogenous Growth Hormone on Ocular Findings
Recruiting NCT06280807 - Observation of Environment and Reproductive-Endocrine Effects
Completed NCT00001202 - Treatment of Boys With Precocious Puberty Phase 2
Completed NCT04665713 - Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
Completed NCT02199587 - The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test N/A
Terminated NCT04502836 - Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study N/A
Completed NCT00006174 - Effects of Letrozole on Precocious Puberty Due to McCune Albright Syndrome Phase 1
Completed NCT02650141 - Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty N/A
Completed NCT00909844 - Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study Phase 3
Completed NCT00004335 - Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle N/A