E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Target population: Male hypogonadism (testosterone deficiency)
As end points
Bone mineralisation
Body composition
Markers of insulin sensitivity and cardiovascular disease
Lipid profile
Hemoglobin concentration amd hematocrit |
Studiepopulation: Manlig hypogonadism (testosteronbrist)
Utfallsparametrar
Bentäthet
Kroppssammansättning
Markörer för insulinkänslighet och kardiovaskulär funktion
Lipid profil
Hemoglobin/hematokrit |
|
E.1.1.1 | Medical condition in easily understood language |
Men with sex hormone deficiency.
Bone mineralisation
Body composition
Markers of insulin action and of cardiovascular disease
Blood lipids
Red blood cells
|
Män med könshormonbrist
Bentäthet
Kroppssammansättning
Insulinkänslighet och hjärt-kärl funktion
Blodfetter
Mängd röda blodkroppar |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067734 |
E.1.2 | Term | Testosterone deficiency |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whethe rlong term complications of androgen deficiency can be prevented by testosterone treatment |
Att undersöka om långtidskomplikationer till testosteronbrist kan förebyggas genom hormonbehandling |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Men 18 to 50 years old, recruited through University Hospitals in Tromsö, Norway and Malmö, Sweden
1. Previously treated for childhood cancer or testicular cancer, or
2. Has completed infertility treatment and has sperm concentration below 20 x 106/mL
• Last cancer treatment >24 months ago.
• Total testosterone below 10 nmol/L and/or LH above 10 IU/L in two repeated samples drawn between 08.00 and 10.00.
|
Män - 18 -50 år
Tidigare behandlade för barn eller testikelcancer eller har genongått behandling för ofrivillig barnlöshet och har spermiekoncentration under 20 milj/mL
Serum testosteron under 10 nmol/L och/eller LH över 10 IU/L vis två mätningar mellan 8 och 10 på morgonen |
|
E.4 | Principal exclusion criteria |
• PSA > upper reference levels (2 pg/L).
• Untreated hypothyreoidism
• Use of statins, antihypertensive or anti-diabetic medication.
• Androgen replacement given within last 6 months prior to inclusion;
• Osteoporosis defined as DEXA L2-L4 t-score below -2.5 ;
• Men wishing or trying to become fathers in the near future (2 year) – for subfertle men the infertility treatment has to be completed at the time of inclusion.;
• Allergy to testosterone undecanoate or any other components of Nebido®;
• Previous or current prostate, breast or liver cancer;
• Sleep apnoea;
• acquired or inherited blood clotting irregularities;
• severe cardiac, hepatic or renal insufficiency or ischemic heart disease;
|
PSA > 2 pg/L
Obehandlad hypothyroidism
Behandling med statiner, antihypertensiv eller anti-diabetes medicin
Androgen behandling inom senaste 6 månader
Osteoporos - DEXA rygg (L2-L4) t-score < -2,5
Män som önskar att bl pappor inom närmaste två år (för subfertila män bör infertilitetsbehandling vara avsluttad)
Allergi för testosteron undecanoat eler andra komponente ri Nebido
Tidigare eller aktuell prostata, bröst eller livercancer
Sömn apnoea
Koagulationsstörning
Alvarlig hjärt-, njur- eller leverinsufficiens eller iskämisk hjärtsjukdom |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
0, 12 and 24 months |
0, 12 och 24 månader |
|
E.5.2 | Secondary end point(s) |
Decrease in fat mass and increase in fat-free mass, measured by DEXA
Components of the metabolic syndrome
Waist circumference, HDL-cholesterol, glucose, triglycerides and blood-pressure.
Sexual life score
Quality of life
Bone mineral density
|
Metabolt syndrom komponenter: midjemått; HDL kolesterol; glukos, triglycerider, blodtryck
Sex-liv score
Livskvalitetsscore
Bentäthet (DEXA) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
0, 12 and 24 months |
0, 12 och 24 månader |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
When the last subject (N=160) has fulfilled the treatment.
|
När den sist inkluderade individen (Nr. 160) har genomförd 24 månaders behandling |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |