Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT00975650
Eligibility 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00975650
Study Brief:
Protocol Section:
NCT00975650