Clinical trial NCT02034487: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Puberty
Keywords: Delayed Puberty
Boys
Hormones
Polymorphism, Genetic
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 451
Sex: MALE
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Age at diagnosis in boys with delayed puberty.
timeFrame: At first evaluation
Secondary outcomes:
measure: Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms
timeFrame: At first evaluation and during first 12 months of observation / treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Growth and Reproduction, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Anders Juul, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.