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

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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

Tracking Information
First Submitted Date January 9, 2014
First Posted Date January 13, 2014
Last Update Posted Date January 13, 2014
Study Start Date January 1990
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2014)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 10, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment
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
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum and white cells
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.
Condition Delayed Puberty
Intervention Other: retrospective data collection
Study Groups/Cohorts Boys with delayed puberty
Boys with no signs of puberty by an age that is -2 standard deviation below the population mean.
Intervention: Other: retrospective data collection
Publications * Lawaetz JG, Hagen CP, Mieritz MG, Blomberg Jensen M, Petersen JH, Juul A. Evaluation of 451 Danish boys with delayed puberty: diagnostic use of a new puberty nomogram and effects of oral testosterone therapy. J Clin Endocrinol Metab. 2015 Apr;100(4):1376-85. doi: 10.1210/jc.2014-3631. Epub 2015 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 10, 2014)
451
Original Actual Enrollment Same as current
Actual Study Completion Date October 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 13 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02034487
Other Study ID Numbers KF01328087
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anders Juul, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Anders Juul, PhD, DMSc Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date January 2014