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Cycled Testosterone Replacement Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00957528
First received: August 10, 2009
Last updated: September 4, 2012
Last verified: September 2012
Results First Received: July 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hypogonadism
Interventions: Drug: Testosterone
Drug: Placebo

  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
Subject recruitment began in January, 2006 and was closed on December, 2011. Subjects were enrolled at the University of Texas Medical Branch in the Institute for Translational Sciences Clinical Research Center (ITS-CRC).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening was conducted at the ITS-CRC where the subject was consented and screening was conducted to identify eligible subjects.Screening included blood testing and a stress test to determine fitness for physical function testing. Subjects were excluded due to elevated PSA levels, testosterone levels above entry criteria or occult disease.

Reporting Groups
  Description
Placebo Weekly placebo treatment for a duration of 5 months.
Monthly Cycled Testosterone A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
Continuous Testosterone Weekly testosterone treatment for a duration of 5 months

Participant Flow:   Overall Study
    Placebo     Monthly Cycled Testosterone     Continuous Testosterone  
STARTED     8     9     9  
COMPLETED     8     8     8  
NOT COMPLETED     0     1     1  
Protocol Violation                 0                 1                 0  
Withdrawal by Subject                 0                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Placebo Weekly placebo treatment for a duration of 5 months.
Monthly Cycled Testosterone A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
Continuous Testosterone Weekly testosterone treatment for a duration of 5 months
Total Total of all reporting groups

Baseline Measures
    Placebo     Monthly Cycled Testosterone     Continuous Testosterone     Total  
Number of Participants  
[units: participants]
  8     9     9     26  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     5     3     2     10  
>=65 years     3     6     7     16  
Age  
[units: years]
Mean ± Standard Deviation
  65.4  ± 3.22     71.6  ± 7.78     73.3  ± 7.54     70.1  ± 6.18  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     8     9     9     26  
Region of Enrollment  
[units: participants]
       
United States     8     9     9     26  



  Outcome Measures
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1.  Primary:   Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months   [ Time Frame: 5 Months ]

2.  Primary:   Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months   [ Time Frame: 5 months ]

3.  Primary:   Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)   [ Time Frame: 5 months ]

4.  Secondary:   Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)   [ Time Frame: 5 months ]

5.  Secondary:   Changes in Serum Markers of Bone Turnover.   [ Time Frame: 5 months ]

6.  Secondary:   9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines   [ Time Frame: 5 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Randall Urban, M.D., Professor of Medicine
Organization: The University of Texas Medical Branch at Galveston
phone: 409- 772-1176
e-mail: rurban@utmb.edu


No publications provided


Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00957528     History of Changes
Other Study ID Numbers: 01-302, GCRC 615, R01 AG022023
Study First Received: August 10, 2009
Results First Received: July 19, 2012
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board