Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

Launched by MERCK SHARP & DOHME LLC · Feb 12, 2007

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• 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