Constitutional Delay of Growth and Puberty: towards evidence-based treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002477-59-FI

Enrollment

Registered

2012-11-20

Start date

2012-12-12

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

constitutional delay of puberty MedDRA version: 14.1 Level: PT Classification code 10012205 Term: Delayed puberty System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Letrozol Orion 2.5 mg tabletti Pharmaceutical Form: Tablet INN or Proposed INN: LETROZOLE CAS Number: 112809-51-5 Concentrat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Clinical and biochemical criteria: Age 14 yrs or more, mean testicular volume >2.5 mL and 2 nM and normal serum DHEAS, even if the mean testicular volume is less than 2.5 ml. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Chronic diseases, primary hypogonadism, chromosomal anomalies, chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment).

Design outcomes

Primary

Measure	Time frame
Main Objective: To study in boys with constitutional delay of puberty, showing very early signs of puberty, whether treatment with the aromatase inhibitor letrozole promotes the progression puberty more efficiently than the current standard of care, low-dose testosterone therapy. ;Secondary Objective: To study whether aromatase inhibitor treatment also results in faster post-treatment progression of puberty, as compared with low-dose testosterone; to study treatment effect on several sex steroid-responsive tissues/pathways, such as bone mineralization, lipid profile, markers of maturing spermatogenesis; to study the treatment influence on measures psychological well-being;Primary end point(s): The primary outcome measures are: testicular volume, urinary LH levels, and circulating hormone values reflecting the activity of the hypothalamic-pituitary-gonadal axis (especially, basal and GnRH-induced LH, FSH, testosterone, inhibin B, AMH levels). Changes in these parameters during treatment are compared between the testosterone and letrozole groups;Timepoint(s) of evaluation of this end point: After all patients in the randomized study have completed the 12 months of follow-up.	—

Measure

Time frame

Main Objective: To study in boys with constitutional delay of puberty, showing very early signs of puberty, whether treatment with the aromatase inhibitor letrozole promotes the progression puberty more efficiently than the current standard of care, low-dose testosterone therapy. ;Secondary Objective: To study whether aromatase inhibitor treatment also results in faster post-treatment progression of puberty, as compared with low-dose testosterone; to study treatment effect on several sex steroid-responsive tissues/pathways, such as bone mineralization, lipid profile, markers of maturing spermatogenesis; to study the treatment influence on measures psychological well-being;Primary end point(s): The primary outcome measures are: testicular volume, urinary LH levels, and circulating hormone values reflecting the activity of the hypothalamic-pituitary-gonadal axis (especially, basal and GnRH-induced LH, FSH, testosterone, inhibin B, AMH levels). Changes in these parameters during treatment are compared between the testosterone and letrozole groups;Timepoint(s) of evaluation of this end point: After all patients in the randomized study have completed the 12 months of follow-up.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary end points are changes in bone mineral density and structure as evaluated by dual-energy x-ray absorptiometry and peripheral quantitative CT; measures of social functioning, body image and self esteem; lipid profile; markers of maturing spermatogenesis ;Timepoint(s) of evaluation of this end point: After all patients in the randomized study have completed the 12 months of follow-up.	—

Measure

Time frame

Secondary end point(s): The secondary end points are changes in bone mineral density and structure as evaluated by dual-energy x-ray absorptiometry and peripheral quantitative CT; measures of social functioning, body image and self esteem; lipid profile; markers of maturing spermatogenesis ;Timepoint(s) of evaluation of this end point: After all patients in the randomized study have completed the 12 months of follow-up.

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Countries

Finland

Contacts

Public ContactLastenendokrinologian vastaanotto

Helsingin yliopistollinen keskussairaala

matti.hero@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026