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

• Status: Completed
• Trial end date: 2018-02-05
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Collaborator: Foundation for Paediatric Research, Finland
• Treatments: Letrozole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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)