Efficacy of an Intranasal Testosterone Product

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01252745
• Date of registration: 01/12/2010
• Primary sponsor: Trimel Biopharma SRL
• Public title: Efficacy of an Intranasal Testosterone Product
• Scientific title: An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
• Date of first enrolment: August 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01252745
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
testosterone levels >100 ng/dl and = 300 ng/dL.

- Normal Otolaryngological nasal endoscopy examination.

- Normal prostate examination (no palpable prostatic mass), and serum PSA = 4.0 ng/mL.

Exclusion Criteria:

- Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
hormones

- Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
months

- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
sinus surgery.

- History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
month, abuse of nasal decongestants) or sleep apnea.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hypogonadism

Intervention(s)

Drug: Testosterone

Primary Outcome(s)

Pharmacokinetic profile of serum testosterone [Time Frame: 7 days]

Secondary ID(s)

TBS-1-2010-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors