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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT00857961
Eligibility Criteria:
Inclusion Criteria:
* Male study participants with a prior documented diagnosis of hypoandrogenism as evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or a Serum testosterone less than or equal to 300 ng/dL
* Were receiving, or in the investigator's opinion were eligible to receive treatment for hypoandrogenism
* Body Mass Index (BMI) less than 35 kg/m\^2
* Passed the required laboratory and physical screening tests
* Haemoglobin levels at screening greater than or equal to 13.0 g/dL
* Adequate venous access on left or right arm
* Able to communicate with study staff, understand the study information sheet and sign the written Informed Consent forms; willing to follow and comply with study procedures
Exclusion Criteria:
* Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens
* Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing
* Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
* Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)
* Any man in whom testosterone therapy is contraindicated, which included those with:
* Known or suspected carcinoma (or history of carcinoma) of the prostate or symptoms of benign prostatic hyperplasia and/or symptoms of lower urinary obstruction,
* Known or suspected carcinoma (or history of carcinoma) of the breast,
* Severe liver damage i.e. cirrhosis, hepatitis or liver tumours,
* Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,
* Significant cerebrovascular or coronary artery disease,
* Known or suspected sleep apnoea,
* Hematocrit \> 51%
* Men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.
* Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests 3 times the upper limit of the normal range values)
* Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, or that were cytochrome P450 inducers or inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin), anti-histamines
* Men involved in sport in which there was screening for anabolic steroids
* Men with uncontrolled diabetes (hemoglobin A1c \[HbA1c\] greater than or equal to 10%)
* Men taking any Investigational Product, or who had received an Investigational Product within 28 days prior to screening or 5 half-lives (whichever was the longer)
* Any contraindication to blood sampling
* Study participants who planned to have a surgical procedure during the course of the study
* Study participants with a partner of child bearing potential who was not willing to use adequate contraception (i.e. condoms) for the duration of the study
* Study participants whose partners were pregnant
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00857961
Study Brief:
Protocol Section:
NCT00857961