Status:
COMPLETED
Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypogonadism
Androgens
Eligibility:
MALE
50+ years
Phase:
PHASE2
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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00434824
Start Date
November 1 2001
End Date
July 1 2004
Last Update
April 16 2015
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