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

Delayed Puberty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034487
• Other study ID #: KF01328087
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 10, 2014
• Start date: January 1990
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyApproval number: 2006-41-7251
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: October 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 20 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Delayed Puberty
• Puberty, Delayed

Intervention

Other:
• retrospective data collection

Locations

Country	Name	City	State
Denmark	Department of Growth and Reproduction, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age at diagnosis in boys with delayed puberty.	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.	At first evaluation	No
Secondary	Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms	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.	At first evaluation and during first 12 months of observation / treatment	No