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TOM: Testosterone in Older Men With Sarcopenia

This study has been terminated.
(Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.)
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shalender Bhasin, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00240981
First received: October 14, 2005
Last updated: February 22, 2017
Last verified: February 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Sarcopenia
Hypogonadism
Muscular Diseases
Interventions: Drug: Topical testosterone gel 1% (active formulation)
Drug: Topical gel (placebo formulation)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants provided written, informed consent. Recruitment took place at VAHCS, NERI, and BUMC. Outcome assessments were performed at BUMC. The study consisted of a 24- week intervention followed by a 12-week observation period. Enrollment took place between September 2005 and December 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The participants were community-dwelling men, aged 65 years and older, with total testosterone between 100 and 350 ng/dL or free testosterone less than 50 pg/mL, and mobility limitation.

Reporting Groups
  Description
Treatment No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Treatment   Placebo
STARTED   106   103 
Intent to Treat Sample   82   83 
COMPLETED   68   70 
NOT COMPLETED   38   33 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter or a free serum testosterone level of less than 50 pg per milliliter were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months.

Reporting Groups
  Description
Treatment Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Placebo Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Total Total of all reporting groups

Baseline Measures
   Treatment   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 106   103   209 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      106 100.0%      103 100.0%      209 100.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 74  (6)   74  (5)   74  (5.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      106 100.0%      103 100.0%      209 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   106   103   209 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in Physical Performance Measured by an Exercise Testing Regimen   [ Time Frame: baseline and 6 months ]

2.  Secondary:   Chest-Press   [ Time Frame: baseline and 6 months ]

3.  Secondary:   Stair-climbing Test (Without a Load)   [ Time Frame: baseline and 6 month ]

4.  Secondary:   Grip Strength   [ Time Frame: baseline and 6 months ]

5.  Secondary:   50-Meter Walking Speed (Without a Load)   [ Time Frame: baseline and 6 months ]

6.  Secondary:   Stair-climbing Test (Loaded)   [ Time Frame: baseline and 6 months ]

7.  Secondary:   Late Life Functional Disability Index (LLFDI)   [ Time Frame: baseline and 6 months ]

8.  Secondary:   Total Lean Mass   [ Time Frame: baseline, 3 months, and 6 months ]

9.  Secondary:   Total Fat Mass   [ Time Frame: baseline, 3 months, and 6 months ]

10.  Secondary:   50-Meter Walking Speed (With a Load)   [ Time Frame: baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shalender Bhasin
Organization: Brigham & Women's Hospital
phone: 617-525-9150
e-mail: sbhasin@partners.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shalender Bhasin, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00240981     History of Changes
Other Study ID Numbers: AG0057
U01AG014369 ( U.S. NIH Grant/Contract )
Study First Received: October 14, 2005
Results First Received: February 8, 2017
Last Updated: February 22, 2017