Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment

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.
 
ClinicalTrials.gov Identifier: NCT02034487
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Anders Juul, Rigshospitalet, Denmark

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the phenotype and biochemical characteristics of boys referred for delayed puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the diagnostic criteria and the effect of testosterone treatment.

Condition or disease Intervention/treatment
Delayed Puberty Other: retrospective data collection

Detailed Description:

Delayed Puberty in Boys; Clinical and biochemical characteristics and effect of testosterone treatment, is a retrospective study in a large case series of Danish boys with delayed puberty.

All boys were referred to the Department of Growth and Reproduction to be evaluated for delayed puberty.

Medical history: Birth length, birth weight, gestational age at birth, medical history (including cryptorchidism and hypospadias), family history of delayed puberty in mother, father and possible siblings.

Physical examination: Pubertal staging according to Tanners classification of boys, genitalia development (G1-G5), pubic hair development (PH1-PH6), axillary hair (yes/no), axillary sweat (yes/no), gynecomastia (yes/no), micropenis (yes/no), height, mother height, father height, target height, weight, BMI, bone age and predicted adult height.

Blood sampling for measurement of hormone levels: Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, anti-mullerian hormone, sex hormone-binding globulin, testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3.

Gonadotropin-releasing hormone stimulation test for measurement of peak FSH and peak LH.

Retrospective DNA analysis looking for common polymorphisms.

If testosterone treatment were initiated, route of administration, dose and duration of treatment were registered.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 451 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment - Retrospective Experience From a Single Tertiary Referral Centre 1990-2013
Study Start Date : January 1990
Actual Primary Completion Date : February 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Boys with delayed puberty
Boys with no signs of puberty by an age that is -2 standard deviation below the population mean.
 Other: retrospective data collection


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Age at diagnosis in boys with delayed puberty. [ Time Frame: At first evaluation ]
    We will evaluate the mean age at diagnosis as well as the age distribution of newly diagnosed boys. These data are compared to age at onset and progression of normal puberty in contemporary healthy Danish boys.


Secondary Outcome Measures :
  1. Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms [ Time Frame: At first evaluation and during first 12 months of observation / treatment ]
    Specifically, genital stage, pubic hair stage, axillary hair, axillary sweat, gynecomastia, micropenis, height, mother height, father height, target height, weight, BMI, bone age and predicted adult height. We will evaluate serum levels of follicle stimulating hormone, luteinizing hormone, estradiol, anti-mullerian hormone, sex hormone-binding globulin, testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3. We will evaluate the effect of candidate polymorphisms suspected to affect pubertal timing, e.g. FSHR, FSHB, FGF23, KISS1, NeurokininB, GnRH, GnRH-R, LH, LH-R, GHRd3.


Biospecimen Retention:   Samples With DNA
serum and white cells

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consisted of boys who were referred to be evaluated for delayed puberty at the Department of Growth and Reproduction between January 1990 and February 2013.
Criteria

Inclusion Criteria:

  • All boys identified in the period from January 1990 to February 2013

Exclusion Criteria:

  • Misclassified (other diagnoses)
  • Insufficient data
  • Lost to follow up
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02034487


Locations
Layout table for location information
Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Anders Juul, PhD, DMSc Rigshospitalet, Denmark
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Anders Juul, PhD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02034487    
Other Study ID Numbers: KF01328087
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Anders Juul, Rigshospitalet, Denmark:
Delayed Puberty
Boys
Hormones
Polymorphism, Genetic
Additional relevant MeSH terms:
Layout table for MeSH terms
Puberty, Delayed
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents