Trial record 3 of 144 for:    puberty

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Juul, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02034487
First received: January 9, 2014
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention
Delayed Puberty
Other: retrospective data collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Age at diagnosis in boys with delayed puberty. [ Time Frame: At first evaluation ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 451
Study Start Date: January 1990
Study Completion Date: October 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034487

Locations
Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Anders Juul, PhD, DMSc Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Anders Juul, PhD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02034487     History of Changes
Other Study ID Numbers: KF01328087
Study First Received: January 9, 2014
Last Updated: January 10, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Approval number: 2006-41-7251

Keywords provided by Rigshospitalet, Denmark:
Delayed Puberty
Boys
Hormones
Polymorphism, Genetic

Additional relevant MeSH terms:
Puberty, Delayed
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 26, 2014