Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism

Condition(s) targeted: Hypogonadism

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

Phase: Phase 2

Status: Completed

Sponsored by: Organon

Official(s) and/or principal investigator(s):
Pierre MG Bouloux, MD, Study Chair, Affiliation: Royal Free and University School of Medicine, London, United Kingdom

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: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline on the total score of the AMS rating scale at Month 6

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

Detailed description: The availability of novel improved androgen preparations has led to a resurgence of interest in late-onset hypogonadism (LOH) and its treatment. The objective of this multicenter, randomized, double-blind, placebo-controlled trial was to investigate the effects of oral testosterone undecanoate (TU) on clinical outcomes associated with LOH. In 14 study centers in 7 European countries, 322 eligible men >50 years with documented testosterone deficiency (calculated free testosterone <0. 26 nmol/L and a positive ADAM questionnaire) were randomized to treatment for 12 months with placebo, oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses. The effects of treatment on LOH symptoms were measured using the Aging Males Symptoms (AMS) rating scale. Blood samples were taken to determine endocrine parameters, bone markers, PSA, Ht, lipids and to perform routine laboratory assessments. Bone mineral density (BMD), lean body mass (LBM) and body fat mass (BFM) were measured using dual energy x-ray absorptiometry. Prostate safety was monitored using prostate specific antigen (PSA) and the International Prostate Symptom Score (IPSS).

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: subjects were at least 50 years of age a body mass index (BMI) between 18 and 34 kg/m2 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.

Organon Investigational Site, Salzburg, Austria

Organon Investigational Site, Gent, Belgium

Organon Investigational Site, Leuven, Belgium

Organon Investigational Site, Liege, Belgium

Organon Investigational Site, Le Kremlin-Bicetre, France

Organon Investigational Site, Giessen, Germany

Organon Investigational Site, Munich, Germany

Organon Investigational Site, Nijmegen, Netherlands

Organon Investigational Site, Utrecht, Netherlands

Organon Investigational Site, Eindhoven, Netherlands

Organon Investigational Site, Zurich, Switzerland

Organon Investigational Site, London, United Kingdom

Organon Investigational Site, Sheffield, United Kingdom

Organon Investigational Site, Aberdeen, United Kingdom

Starting date: November 2001
Ending date: July 2004
Last updated: February 12, 2007