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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT01327495
Eligibility Criteria:
Inclusion Criteria:
In good health, without severe systemic illness (i.e., renal, liver, cardiac or lung disease, cancer, insulin dependent diabetes)
* Male between the ages of 25 and 55 years old
* Able to understand and comply with protocol instructions and requirements
* International Prostate Symptom Score (IPSS) \<11
* Agrees to not donate blood during the study
* Normal serum total T, LH, FSH, urine analysis, COMP, CBC and sperm count
Exclusion Criteria:
* History of, or current breast cancer or prostate cancer
* Clinically significant findings on digital rectal exam such as nodules, areas of induration or any other malignancy or abnormal prostate ultrasound
* History of invasive therapy for BPH
* Current or past treatment with a 5α-reductase inhibitor
* History of drug or alcohol abuse within the past 12 months
* History of a bleeding disorder or anticoagulation
* Skin disease that might interfere with T-gel absorption
* Participation in another drug study in the past 3 months
* A first-degree relative (i.e. father, brother) with a history of prostate cancer
* History of infertility or desire for fertility within 6 months, or current pregnant female partner
* Weight \>320 pounds or BMI \> 40
* PSA Level \> 2.1
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT01327495
Study Brief:
Protocol Section:
NCT01327495