MICROPENIS DUE TO HYPOGONADOTROPIC HYPOGONADISM MedDRA version: 9.1 Level: SOC Classification code 10014698
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Testosterone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical Form: Powder and
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Testosterone and gonadotropins concentrations compatible with ``minipuberty``
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of two randomized therapeutical regimens for treatment of micropenis;Secondary Objective: - Role of hormonal markers (inhibin, antimullerian hormone)in diagnosis and evaluation of therapeutic response. - Long term outcome in terms of pubertal testicular volume and future fertility;Primary end point(s): Increase of testicular volume (evaluated by orchidometry or by US scan) at least twice than diagnosis | — |
Countries
Italy
Outcome results
None listed