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

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency

Conditions
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Hypogonadism, Androgens

Intervention / Treatment
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* Drug: Oral testosterone undecanoate (Andriol)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Oral testosterone undecanoate (Andriol) | Drug: Oral testosterone undecanoate (Andriol)<br>* treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses<br>* Other names: Org 538;|
| Placebo Comparator: Arm 2<br>Placebo | Drug: Placebo<br>* treatment for 12 months with placebo in divided doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the total score of the AMS rating scale |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids |  | Month 12 |