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

Constitutional Delay of Growth and Puberty Clinical Trial

— CDGP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797718
• Other study ID #: EudraCT:2012-002477-59
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 18, 2013
• Last updated: February 5, 2018
• Start date: October 2013
• Est. completion date: February 5, 2018

Study information

• Verified date: February 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 5, 2018
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constitutional Delay of Growth and Puberty

Intervention

Drug:
• Testosterone
1mg/kg every 4 weeks for 6 months
• 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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Kotka Central Hospital	Kotka
Finland	Kuopio University Central Hospital	Kuopio
Finland	Turku University Central Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Foundation for Paediatric Research, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	testicular volume	Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo	one year
Primary	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)	one year
Secondary	Bone health	Several endpoints related to bone health	one year
Secondary	Psychosocial well-being	Psycho-social well-being will assessed with questionnaires.	one year
Secondary	Puberty-related metabolical and clinical changes	Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.	one year