Completed

NCT Number: NCT01797718

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

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.

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Key information

Conditions

Constitutional Delay of Growth and Puberty

Age range

14 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Helsinki University Central Hospital, Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Testosterone

Drug

1mg/kg every 4 weeks for 6 months

Other names: Sustanon 250

letrozole

Drug

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

Other names: Letrozole Bluefish, Letrozole Orion, Letrozole Accord, Letrozole Sandoz, Femar

Primary outcomes

testicular volume

Time frame: one year

Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo
clinical and biochemical measures of pubertal progression

Time frame: one year
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)

Secondary outcomes

Bone health

Time frame: one year

Several endpoints related to bone health
Psychosocial well-being

Time frame: one year

Psycho-social well-being will assessed with questionnaires.
Puberty-related metabolical and clinical changes

Time frame: one year

Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

Foundation for Paediatric Research, Finland

Registry information

Acronym: CDGP

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2018
First posted: Feb 22, 2013
Registry last updated: Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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