NCT01797718

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: Male
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constitutional Delay of Growth and Puberty

Interventions

Type	Name	Description
DRUG	Testosterone	1mg/kg every 4 weeks for 6 months
DRUG	Letrozole	2.5mg daily for 6 months. Safety criteria: if testosterone level is above 30nM at 3 months, the dosage is reduced to 2.5mg every other day

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-03-20
• Completion: 2018-02-05
• First posted: 2013-02-22
• Last updated: 2018-02-06

Locations

4 sites across 1 country: Finland