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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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