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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT01370369
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-65
* History of hypogonadism
* In good health based on medical history, physical examination and clinical laboratory tests
* Screening morning serum testosterone ≤ 297 ng/dL
* One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
* Body mass index (BMI) between 18 and 31
Exclusion Criteria:
* Prostate cancer
* Palpable prostatic mass(es)
* Generalized skin irritation or significant skin disease
* Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole)
* Clinically significant anemia or renal dysfunction
* Hyperparathyroidism or uncontrolled diabetes
* Serum PSA Levels; ≥ 4ng/mL
* History of cardiovascular disease
* Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
* Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01370369
Study Brief:
Protocol Section:
NCT01370369