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

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

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

Sponsors & Collaborators

• Foundation for Paediatric Research, Finland

  collaborator OTHER

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Taneli Raivio, MD, PhD · Helsinki University Central Hospital

• Matti Hero, MD, PhD · Helsinki University Central Hospital

• Tero Varimo, MD, PhD · Helsinki University Central Hospital

• Päivi Miettinen, MD, PhD · Helsinki University Central Hospital

• Jorma Toppari, MD, PhD · University of Turku

• Hanna Huopio, MD, PhD · Kuopio University Central Hospital

• Sirpa Tenhola, MD, PhD · Kymeenlaakso Central Hospital

• Raimo Voutilainen, MD, PhD · Kuopio University Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

17 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2017-03-20

Completion

2018-02-05

Countries

• Finland

Study Locations