NCT00434824

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

2.7 years

First QC Date

February 12, 2007

Last Update Submit

April 15, 2015

Conditions

HypogonadismAndrogens

Outcome Measures

Primary Outcomes (1)

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

    Month 6

Secondary Outcomes (1)

  • 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Oral testosterone undecanoate (Andriol)

Drug: Oral testosterone undecanoate (Andriol)

Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

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

Also known as: Org 538
Arm 1
PlaceboDRUG

treatment for 12 months with placebo in divided doses

Arm 2

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Meuleman EJ, Legros JJ, Bouloux PM, Johnson-Levonas AO, Kaspers MJ, Elbers JM, Geurts TB, Meehan AG; Study 43203 Investigators. Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism. Aging Male. 2015;18(3):157-63. doi: 10.3109/13685538.2015.1032925. Epub 2015 Jun 1.

    PMID: 26030346DERIVED

  • Bouloux PM, Legros JJ, Elbers JM, Geurts TB, Kaspers MJ, Meehan AG, Meuleman EJ; Study 43203 Investigators. Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year, randomized, placebo-controlled, dose-ranging study. Aging Male. 2013 Jun;16(2):38-47. doi: 10.3109/13685538.2013.773420. Epub 2013 Apr 12.

    PMID: 23581697DERIVED

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 13, 2007

Study Start

November 1, 2001

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

April 16, 2015

Record last verified: 2015-04