Delayed or absence of puberty MedDRA version: 15.1 Level: LLT Classification code 10012180 Term: Delay in sexual development and puberty, not elsewhere classified System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Testoviron Depot® Soulution for injection i.m.
250mg/mL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TESTOSTERONE
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Västra Götalandsregionen (VGR)
Sahlgrenska Academy-Gothenburg University Institute
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Group I (absent puberty): 1.Signed informed consent 2.Healthy young male subjects 14-16 years old 3.Morning serum testosterone value by inclusion (07.30-09.00) and start (08.00-10.00) that is less 0.5 nmol/L 4.Pre-pubertal LHRH test 5.Testicular volume 1-3ml bilaterally 6.Bone age 11 years or older 7.Otherwise clinically normal physical findings and laboratory values as judged by the investigator Group II (Delayed puberty): 1.Signed informed consent 2.Healthy young male subjects 14-16 years old 3.Morning serum testosterone by inclusion (07.30-09.00) of 1 – 3 nmol/L and at start (08.00-10.00) less than 4 nmol/L 4.Testicular volume 4-6 mL bilaterally 5.Bone age more than 11 years or older Are the trial subjects under 18? yes Number of subjects for this age range: 70 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: 1.Growth spurt 2.Bone age <11 years 3.Untreated hypothyroidism 4.Suspected growth hormone deficiency 5.Untreated celiac disease 6.Steroid or immuno suppression medicated disease 7.Training doses over 10 hours a week 8.Known or suspected allergic reaction towards the active substances or other components 9.Clinical judgement by the investigator that the subject should not participate in the study 10.Use of anabolic steroids or other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to: -Evaluate the effect of Testoviron Depot® and Nebido® on pubertal development in young males with delayed puberty -Study the effect of Testoviron Depot® and Nebido® in combination with Puregon in young males with absent of puberty. ;Secondary Objective: -Serum testosterone levels during treatment with Testoviron Depot® and Nebido® -Signs of masculinization -Health-related quality of life (KIDSCREEN, JTJÄ).;Primary end point(s): The primary endpoint in group I (abscent puberty) will be increase in blood LH after GnRH test. Testis size =8 mL will be the primary endpoint for group II (delayed puberty) ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Increase in testis size from baseline to 1 year •Serum testosterone levels during treatment with Testoviron Depot® and Nebido®. •Signs of masculinization from baseline to 3, 6 and 12 months •Body growth •Hair growth measured as tanner stage and inspection of axillaries hair •Deepening of voice •Gender identity •Health-related quality of life (KIDSCREEN, JTJÄ) ;Timepoint(s) of evaluation of this end point: 6 and 12 months | — |
Countries
Sweden
Contacts
Public ContactPediatric Clinic
Västra Götalandsregionen (VGR)
Outcome results
None listed