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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434824
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Hypogonadism Androgens Drug: Oral testosterone undecanoate (Andriol) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2001
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Arm Intervention/treatment
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 Name: Org 538

Placebo Comparator: Arm 2
Drug: Placebo
treatment for 12 months with placebo in divided doses

Primary Outcome Measures :
  1. Change from baseline on the total score of the AMS rating scale [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00434824    
Other Study ID Numbers: 43203
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents