Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clarus Therapeutics, Inc.
With
inVentiv Health Clinical
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
You may not be if
Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
Untreated, severe 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 mg/dL
BMI \> or equal to 38
Stable doses of lipid-lowering medication for less than three months
Stable doses of oral medication for diabetes for less than two months
Abnormal prostate digital rectal examination \[palpable nodule(s)\], elevated PSA (serum PSA \>3.9 ng/mL), IPSS score \> or equal to 19 points, and /or history of prostate cancer.
History of breast cancer
Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
Known history of abuse of alcohol or any drug substance with 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 initial dose administration in this study
Clareo Health | Safety and Efficacy Trial of Testosterone Undecanoate
