Hypogonadotropic hypogonadism in male newborn - ND

• Conditions: MICROPENIS DUE TO HYPOGONADOTROPIC HYPOGONADISM; MedDRA version: 9.1Level: SOCClassification code 10014698

• Registration Number: EUCTR2008-008299-14-IT
• Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Male newborns affected by micropenis with or without hypospadia or cryptorchidism within 6 months of age - Not previously treated with testosterone or gonadotropins
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Testosterone and gonadotropins concentrations compatible with ``minipuberty``

Study & Design

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