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

Phase 2

Completed

• Conditions: Constitutional Delay of Growth and Puberty
• Interventions: Drug: Testosterone; Drug: Letrozole

• Registration Number: NCT01797718
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-22
• Study Start: 2013-10
• Primary Completion: 2017-03-20
• Status Verified: 2018-02
• Study Completion: 2018-02-05
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

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Exclusion Criteria

• Chronic diseases
• Primary or secondary hypogonadism
• Chromosomal anomalies
• Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone	Testosterone	\~1mg/kg every 4 weeks for 6 months
Letrozole	Letrozole	2.5mg daily for 6 months

Primary Outcome Measures

Name	Time	Method
testicular volume	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	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 Outcome Measures

Name	Time	Method
Bone health	one year	Several endpoints related to bone health
Psychosocial well-being	one year	Psycho-social well-being will assessed with questionnaires.
Puberty-related metabolical and clinical changes	one year	Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.

Trial Locations

Locations (4)

Kotka Central Hospital; 🇫🇮 Kotka, Finland

Kuopio University Central Hospital; 🇫🇮 Kuopio, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Turku University Central Hospital; 🇫🇮 Turku, Finland