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 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT00756561
Eligibility Criteria:
Inclusion Criteria:
* males between 18 and 50 years of age
* sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology
* in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)
* body mass index ≥18 and ≤32 kg/m2
* must agree not to participate in another research study involving drug exposure for the duration of the study
Exclusion Criteria:
* men in poor general health, with abnormal blood results
* sperm counts \<20 million/ml on two tests
* chronic, ongoing alcohol or drug abuse
* participation in a long-term male contraceptive study within the past three months
* history of testicular or scrotal surgery
* history of infertility
* abnormal testicular exam
* abnormal DRE
* chronic pain syndrome
* use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids
* known bleeding disorder
* use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00756561
Study Brief:
Protocol Section:
NCT00756561