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

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

Completed

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Key information

Conditions

Hypogonadism Androgens Endocrine System Diseases Gonadal Disorders

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral testosterone undecanoate (Andriol)

Drug

treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses

Other names: Org 538

Placebo

Drug

treatment for 12 months with placebo in divided doses

Primary outcomes

Change from baseline on the total score of the AMS rating scale

Time frame: Month 6

Secondary outcomes

Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids

Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2004
Study completion: 2004
First posted: Feb 13, 2007
Registry last updated: Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed