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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT01215292
Eligibility Criteria:
INCLUSION CRITERIA:
* Males age 18-50
* Normal serum testosterone, LH and FSH
* prostate-specific antigen (PSA) \< 4.0
* Agrees not to donate blood or participate in another research study during the study
* Informed consent
* Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
* In general good health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry and hematology)
* Must be willing to use a reliable form of contraception during the study
EXCLUSION CRITERIA:
* Poor general health, with clinically significant abnormal blood results
* Participation in a long-term male contraceptive study within the past three months
* Participation in long-term contraceptive or drug study within the past 3 months
* History of or current liver disease
* Current use of terfenadine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
* History of testicular, prostate, or scrotal surgery/trauma or genital abnormal exam
* BMI \> 32
* History of sleep apnea and/or major psychiatric problems
* Chronic pain syndrome
* History of testosterone or anabolic steroid abuse currently or in the past
* Known bleeding disorder or current use of anticoagulation
* History of or current skin disorder that will interfere with testosterone gel
* Unwilling to adhere to protocol-stated restrictions while in the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01215292
Study Brief:
Protocol Section:
NCT01215292