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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Androgens; Hypogonadism

Treatments: Drug: Oral testosterone undecanoate (Andriol); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434824

43203

Details and patient eligibility

About

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

Enrollment: 322 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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322 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

Oral testosterone undecanoate (Andriol)

Treatment:

Drug: Oral testosterone undecanoate (Andriol)

Arm 2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo