Short-term effects of two drugs containing testosterone on neuro-physiological function

Short-term effects of testosterone enhantate and gel on neuro-physiological function

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001734-17-IT

Enrollment

Registered

2013-10-22

Start date

2014-04-23

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HYPOGONADISM MedDRA version: 16.1 Level: PT Classification code 10058359 Term: Hypogonadism System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: tostrex Pharmaceutical Form: Cutaneous solution INN or Proposed INN: TESTOSTERONE Other descriptive name: prostakan Concentration unit: g gram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: HYPOGONADISM; HEALTHY VOLUNTEERS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: ALL DISEASES EXCEPT HYPOGONADISM; USE OF DRUGS

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: NOT APPLICABLE;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;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: 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;Secondary Objective: NOT APPLICABLE;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;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): NOT APPLICABLE;Timepoint(s) of evaluation of this end point: NOT APPLICABLE	—

Countries

Italy

Contacts

Public ContactSecretariat of Rectorate

University of Rome Foro Italico

rettorato@uniroma4.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026