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

April 15, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 2
Placebo
Drug: Placebo
treatment for 12 months with placebo in divided doses
Active Comparator: Arm 1
Oral testosterone undecanoate (Andriol)
Drug: Oral testosterone undecanoate (Andriol)
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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