Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment

Helsinki University Central Hospital35 enrolled

Overview

Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster biochemical and clinical progression of puberty as compared to low-dose intramuscular testosterone Rx (\~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful waiting instead of medication will provide background data on the natural progression of CDGP, and their data will not be used in primary statistical comparisons.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Constitutional Delay of Growth and Puberty

Interventions

Eligibility

Sex: MALEMin age: 14 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Constitutional delay of growth and puberty * Age 14 years or more * mean testicular volume 2.5 ml or more and less than 4 ml * serum testosterone level less than 5 nM OR as above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean testicular volume is less than 2.5 ml OR as above, but tanner stage G2 and testosterone level less than 3 nM Exclusion Criteria: * Chronic diseases * Primary or secondary hypogonadism * Chromosomal anomalies * Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)

Locations (4)

Helsinki University Central Hospital

Helsinki, Finland

Kotka Central Hospital

Kotka, Finland

Kuopio University Central Hospital

Kuopio, Finland

Turku University Central Hospital

Turku, Finland

Outcomes

Primary Outcomes

testicular volume

Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo

Time frame: one year

clinical and biochemical measures of pubertal progression

Activity of the hypothalamic-pituitary-gonadal axis, evaluated by * genital and pubic hair stage of puberty according to Tanner; * growth velocity (cm/yr); * basal and gonadotropin-releasing hormone (GnRH)-stimulated gonadotropin levels; * urinary luteinizing hormone levels; * testosterone; * inhibin B; * anti-mullerian hormone (AMH)

Time frame: one year

Secondary Outcomes

Bone health

Several endpoints related to bone health

Time frame: one year

Psychosocial well-being

Psycho-social well-being will assessed with questionnaires.

Time frame: one year

Puberty-related metabolical and clinical changes

Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.

Time frame: one year