A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

Launched by ELI LILLY AND COMPANY · Mar 19, 2013

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits
• • At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
• • Prostate Specific Antigen (PSA) \<4 nanogram per milliliter (ng/ml) at screening
• Exclusion Criteria:
• • Sexual partner who is or becomes pregnant at any time during the study
• • Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
• • Body Mass Index (BMI) \>37 kilogram per square meter (kg/m\^2) at screening
• • Severe lower urinary tract symptoms and/or significant prostate enlargement
• • Prolactin lab test result of \>30 ng/mL at screening
• • Hemoglobin A1c (HbA1c) \>11% at screening
• • Hematocrit ≥50% (\>54% at elevated altitude) at screening
• • Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone
• • Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
• • Currently receiving treatment with cancer chemotherapy or antiandrogens
• • Chronic use of systemic glucocorticoids (use for \>14 days within the 3 months prior to screening); use of non-testosterone anabolic steroids within 12 months prior to screening
• • Competitive athletes involved in a sport in which they may be screened for anabolic steroids
• • History of use of estrogenizing agents within 12 months prior to screening
• • History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening
• • History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening
• • Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening
• • Current use of warfarin or phenprocoumon
• • History of frequent opioid use: \>1 time/week during any week within 30 days prior to screening
• • Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine)
• • Have a history of significant central nervous system injuries or disease (including stroke, spinal cord injury, or multiple sclerosis) within 6 months prior to screening
• • Systolic blood pressure \>170 or \<90 millimeter of mercury (mm Hg) or diastolic blood pressure \>100 or \<50 mm Hg at screening or a history of malignant hypertension
• • History of unstable angina as defined by Braunwald Classification of Unstable Angina or angina occurring during sexual intercourse in the last 6 months
• • History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (angioplasty or stent placement)
• • Have any supraventricular arrhythmia with an uncontrolled ventricular response \[mean heart rate \>100 beats per minute (bpm)\] at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate \>100 bpm for ≥30 seconds), or use of an automatic internal cardioverter-defibrillator
• • Have a history of sudden cardiac arrest
• • Exhibit any evidence of congestive heart failure \[New York Heart Association (NYHA) Class 2 or above\], within 6 months prior to screening
• • Have had a new, significant cardiac conduction defect within 90 days prior to screening
• • Clinical suspicion (or history) of prostate cancer during digital rectal examination at screening
• • Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)
• • Exhibit evidence of severe renal impairment \[creatinine clearance \<30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula\] at screening
• • Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at screening
• • Have a history of human immunodeficiency virus (HIV) infection
• • Severe sleep apnea
• • Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (other than hypogonadism) that contributes to symptoms of low energy or fatigue