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

Phase 2

Completed

• Conditions: Androgens; Hypogonadism
• Interventions: Drug: Placebo; Drug: Oral testosterone undecanoate (Andriol)

• Registration Number: NCT00434824
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2007-02-12
• Study First Submitted QC: 2007-02-12
• Study First Posted: 2007-02-13
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 322

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	Placebo
Arm 1	Oral testosterone undecanoate (Andriol)	Oral testosterone undecanoate (Andriol)

Primary Outcome Measures

Name	Time	Method
Change from baseline on the total score of the AMS rating scale	Month 6

Secondary Outcome Measures

Name	Time	Method
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