Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency
Brief Summary: In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.

Specifically, we have studied the effects on:

* symptoms suggestive of low testosterone levels
* blood testosterone and other hormone levels
* bone mass
* muscle mass and fat mass
* muscle strength
* prostate
* lipids, hematocrit


Options:
A: Inclusion Criteria:

* Subjects were at least 50 years of age
* A body mass index (BMI) between 18 and 34 kg/m\^2
* Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
* Calculated free testosterone measurement of \<0.26 nmol/L in the morning

Exclusion Criteria:

* History or current diagnosis of breast or prostate cancer
* any clinically significant abnormal finding on physical examination including the prostate
* Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) \>14)
* Prostate specific antigen (PSA) level \> 4 ng/mL at screening
* Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
* Hyperprolactinaemia or treatment with prolactin-lowering drugs
* History of known chronic polycythemia and/or hematocrit \>50% at screening
* History or presence of severe sleep apnea
* Unstable or untreated endocrine disorders
* History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
* Use of medication that would interfere with the efficacy and safety objectives of the trial
B: Inclusion Criteria:

1. Subjects were to have completed Study CLAR-09007.
2. Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
3. Subjects were required to remain off all forms of T except for study medication throughout the entire study.
4. Subjects voluntarily gave written informed consent to participate in this study.

Subjects meeting any of the following criteria were not eligible for participation in this study:

1. Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness developed during the Phase III study that would, in the opinion of the Investigator, require exclusion from this study.
2. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
3. Serum transaminases \>2 times upper limit of normal (ULN), serum bilirubin \>2.0 mg/dL and serum creatinine \>2.0 mg/dL at the final visit for Study CLAR 09007.
4. Abnormal prostate digital rectal examination (palpable nodule\[s\]) or elevated PSA (serum PSA \>4 ng/mL) at the final visit for Study CLAR-09007.
5. Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or dehydroepiandrosterone (DHEA).
6. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors (e.g., orlistat \[Xenical\]) and bile acid-binding resins (e.g., cholestyramine \[Questran\], colestipol \[Colestid\]).
7. Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
8. Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g., barbiturates, glucocorticoids \[pharmacologic doses of glucocorticoids for replacement therapy were not exclusionary\]) and potent CYP3A4 inhibitors (e.g., human immunodeficiency virus \[HIV\] antivirals \[indinavir, nelfinavir, ritonavir, saquinavir, delaviridine\], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note: Short-term ciprofloxacin administration completed more than 7 days prior to study visits was not exclusionary during the study.)
C: Inclusion Criteria:

* Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

Exclusion Criteria:

* Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
* Recent history of stroke, not including transient ischemic attack
* Untreated, sever obstructive sleep apnea.
* Hematocrit \<35% or \>48
* Serum transaminases \>2 times upper limit of normal, serum bilirubin \> 2.0 mg/dL and serum creatinine \> 2.0 mgk/dL
* BMI \> or equal to 36
* Stable doses of lipid-lowering medication for less than 3 months
* Stable doses of oral medication for diabetes for less than 2 months
* Abnormal prostate DRE \[palpable nodule(s)\], elevated PSA (\>4 ng/mL), IPSS score \> or equal to 19 points.
* History of breast cancer
* Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
* Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
* History of abuse of alcohol or any drug substance within the previous 2 years
* Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
* Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
* Blood donation within the 12 week period before the initial study dose.
D: Inclusion Criteria:

* Men between 45 and 80 years age
* Participants with low serum testosterone concentrations (\< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion Criteria:

* Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
* Participants with prostate specific antigen (PSA) \> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
* Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
* Confirmed testosterone \< 100 ng/dL
* Body Mass Index (BMI) \> 50
* Hemoglobin A1c (HbA1C) \> 11%
* Hematocrit (Hct) \> 50%
* Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min
* History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).

Answer: A