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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT00729859
Eligibility Criteria:
Inclusion Criteria:
* Males age 18-55 years
* Normal serum total testosterone (300 ng/dl-1000 ng/dl)
* Normal LH and FSH levels
* Taking no regular medications
* Normal baseline serum hematology, chemistry and liver function tests
* Agrees not to donate blood during the study
* Agrees to use a form of contraception during the study
* Subject must be able to comply with all study procedures
Exclusion Criteria:
* Clinically significant screening assessments or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments, which may limit participation or prevent completion of the study
* History of prostate cancer, breast cancer, or benign prostatic hypertrophy
* Prostate-specific antigen (PSA) \> 3.0
* History of regular, chronic testosterone or anabolic steroid use in the past year
* Chronic medical illness, prostate disease, or cardiovascular disease
* History of a bleeding disorder or need for anticoagulation
* Skin condition that might interfere with or be exacerbated by T gel use
* Sitting systolic blood pressure \> 180mm Hg or \<90 mm Hg or sitting diastolic blood pressure \>110 mm Hg or \< 60 mm Hg.
* History of clinically significant, untreated sleep apnea
* Participation in another drug-related research study within the past 2 months
* Participating in a regular physical relationship with a pregnant woman
* History of hypersensitivity to any of the study medications (T gel, anastrozole, acyline)
* History of medical or surgical therapy for benign prostatic hypertrophy
* Hematocrit \> 55%
* History of drug or alcohol abuse within last 6 months
* Abnormal digital rectal exam at screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00729859
Study Brief:
Protocol Section:
NCT00729859