Overview

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.