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

Helsinki University Central Hospital (HUCH)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Constitutional Delay of Growth and Puberty

Treatments

Drug: Letrozole

Drug: Testosterone

Study type

Interventional

Funder types

Other

Identifiers

NCT01797718

EudraCT:2012-002477-59

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Male

Ages

14 to 17 years old

Volunteers

No Healthy Volunteers

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)