hypogonadism low testosterone levels in men
Conditions
Interventions
testosterone intranasal gel
Sponsors
Trimel BioPharma SRL
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male human subjects within the age range of 18 to 45 years inclusive 2. Willingness to provide written informed consent to participate in the study 3. Body-mass index less than 30 kg/m2 4. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during screening 5. Normal otorhinolaryngological examination 6. Non-smokers for at least six months 7. Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol
Exclusion criteria
Exclusion criteria: 1. Personal / family history of allergy or hypersensitivity to testosterone or related drugs 2. Past history of anaphylaxis or angioedema 3. Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc. 5. Hemoglobin 52% during screening 6. Any cardiac, renal or liver impairment, any other organ or system impairment 7. History of seizure or clinically significant psychiatric disorders 8. Presence of disease markers for HIV 1 and/or 2, Hepatitis B and/or C virus 9. History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, (*nose job*), or sinus surgery 10. Subject with prior nasal fractures 11. Subject with active allergies, such as rhinitis, rhinorrhea, or nasal congestion 12. Subject with mucosal inflammatory disorders, specifically pemphigus, or Sjogren*s syndrome 13. Subject with sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis 14. History of nasal disorders (e.g. polyposis, recurrent epistaxis (> 1 nose bleed per month), abuse of nasal decongestants or sleep apnea 15. Subject using any form of intranasal medication delivery, specifically nasal corticosteroids and oxymetazoline containing nasal sprays (e.g. Dristan 12-Hour Nasal Spray) 16. History of asthma and/ or on-going asthma treatment 17. Regular drinkers of more than three (3) units of alcohol daily (1 unit = 300 ml beer, 1 glass wine, 1 measure spirit), or consumption of alcohol within 48 hours prior to dosing and during the study. 18. Volunteer demonstrating a positive test for alcohol consumption (using breath alcohol analyzer) at the time of check-in during the admission periods. 19. History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit 20. Volunteers demonstrating a positive test for drugs of abuse in urine (Opiates, Benzodiazepines, Amphetamines, THC and cocaine) at the time of check-in during admission periods 21. Inaccessibility of veins in left and right arm 22. Receipt of any prescription drug therapy within four weeks of the first admission period. 23. Difficulty in abstaining from OTC medication (except occasional paracetamol/aspirin) for the duration of the study 24. Volunteers demonstrating serum PSA >= 4ng/ml 25. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study. 26. Blood donation (usually 550 ml) at any time during this study, or within the 12 week period before the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine a pharmacokinetic profile of testosterone for all subjects in all treatments by measuring: • Cmin, Cmax, and tmax for the 12 hour interval. • AUC0-12, and Cavg. • The relative pharmacokinetic profile of three different formulations of intranasal testosterone will be determined using the AUC0-12h and Cmax0-12h corrected for the endogenous serum testosterone concentrations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety • DHT levels • Vital Signs (Blood Pressure, Body Temperature, Respiratory Rate, Heart Rate). • Physical and otorhinolaryngological examination. • Complete Blood Count: white blood count, hemoglobin and hematocrit. • Clinical chemistry profile: Na/K, glucose, urea, creatinine, calcium, phosphate, uric acid, total bilirubin, albumin, AST, ALT, ALP, GGT and CK. • Urinalysis. | — |
Countries
Netherlands
Outcome results
None listed