Efficacy and Tolerability of an Intra-Nasal Testosterone Product

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acerus Pharmaceuticals Corporation; Trimel Biopharma SRL
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.