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

Phase 1

• Conditions: constitutional delay of puberty; MedDRA version: 14.1 Level: PT Classification code 10012205 Term: Delayed puberty System Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-002477-59-FI
• Lead Sponsor: Taneli Raivio, Helsingin yliopistollinen keskussairaala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Clinical and biochemical criteria: Age 14 yrs or more, mean testicular volume >2.5 mL and <4mL, serum testosterone <5 nM and the adolescent wants medical intervention. No signs of chronic diseases accounting for the delayed puberty.
Biochemical criteria: As above, but serum testosterone >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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified