E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HYPOGONADISM |
IPOGONADISMO |
|
E.1.1.1 | Medical condition in easily understood language |
REDUCTION OF TESTOSTERONE LEVEL IN BLOOD |
RIDUZIONE DEI LIVELLI DI TESTOSTERONE NEL SANGUE |
|
E.1.1.2 | Therapeutic area | Health Care [N] - Population Characteristics [N01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058359 |
E.1.2 | Term | Hypogonadism |
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 |
Few data on the role of short-term effects of testosterone on neuromuscular (NM) function in humans exist. On these basis the aim of this exclusively physiological protocol is to asses possible short-term effects of testosterone on NM functions in males. Particularly, we would like to investigate on the possible non-genomic/short-term effects of testosterone on NM function, by using a non-invasive surface electromyography in vivo. To this end we will evaluate healthy and hypogonadic-hypotestosteronemic male volunteers of different ages (20-40 years and > 60 years). All the volunteers will be submitted to a surface dynamometric- electromyography investigation (i.e to evaluate maximal voluntary isometric contractions, maximal isokinetic contractions, maximal twitch, isometric fatiguing contraction; twitch after fatigue) and to blood/saliva collections (i.e. to evaluate androgens) before and at different time points during/after the administration of testosterone enhantate and ge |
Purtroppo, esistono pochi dati sul ruolo degli effetti a breve termine del testosterone sulle funzioni neuromuscolari (NM). Lo scopo di questo progetto prettamente fisiologico è di valutare i possibili effetti a breve termine del testosterone sulla funzione NM negli uomini. In particolar modo, esaminando i possibili effetti non genomici a breve termine del testosterone sulla funzione NM, utilizzando l’elettromiografia di superficie non-invasiva in vivo. Per questo scopo valuteremo volontari maschi sani e ipogonadici-ipotestosteronemici di diverse età (20-40 anni e > 60 anni). Tutti i volontari saranno sottoposti ad una elettromiografia di superficie non invasiva (per valutare la massima contrazione volontaria; le massime contrazioni isocinetiche; la scossa singola massimale; la contrazione isometrica affaticante; la scossa singola dopo affaticamento) e alla raccolta di sangue/saliva (per valutare gli androgeni) prima e a differenti tempi durante/dopo la somministrazione di testosterone |
|
E.2.2 | Secondary objectives of the trial |
NOT APPLICABLE |
NON APPLICABILE |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
HYPOGONADISM; HEALTHY VOLUNTEERS |
IPOGONADISMO; VOLONTARI SANI |
|
E.4 | Principal exclusion criteria |
ALL DISEASES EXCEPT HYPOGONADISM; USE OF DRUGS |
tutte le patologie eccetto l'ipogonadismo/ipoandrogenismo; uso di
farmaci e integratori |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To asses possible non-genomic/short-term effects of testosterone on
neuromuscular function, by using a non-invasive surface
electromyography in vivo |
Valutare i possibili effetti non genomici a breve termine del testosterone
sulla funzione neuromuscolare, utilizzando l'elettromiografia di superfice
non invasiva in vivo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study |
A fine studio |
|
E.5.2 | Secondary end point(s) |
NOT APPLICABLE |
NON APPLICABILE |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
NOT APPLICABLE |
NON APPLICABILE |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
|
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |