We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Testosterone Trials in Older Men

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00799617
First Posted: December 1, 2008
Last Update Posted: October 12, 2017
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.
Collaborators:
National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: January 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Andropause
Interventions: Drug: AndroGel® (testosterone gel)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AndroGel® (Testosterone Gel)

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo Gel

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.


Participant Flow for 8 periods

Period 1:   Main Testosterone Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   395   395 
COMPLETED [1]   376 [2]   374 
NOT COMPLETED   19   21 
Randomized in error                1                1 
Lost to Follow-up                18                20 
[1] The Testosterone Trials are a coordinated set of 7 trials.
[2] Participants qualified for 1 of the 3 main trials (sexual function, physical function, vitality).

Period 2:   Sexual Funtion Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   234   236 
COMPLETED   218   215 
NOT COMPLETED   16   21 
Lost to Follow-up                12                14 
No Baseline Data                4                7 

Period 3:   Physical Function Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   191   196 
COMPLETED   185   185 
NOT COMPLETED   6   11 
Lost to Follow-up                6                11 

Period 4:   Vitality Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   236   238 
COMPLETED   229   216 
NOT COMPLETED   7   22 
Lost to Follow-up                7                22 

Period 5:   Cardiovascular Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   88   82 
COMPLETED   73   65 
NOT COMPLETED   15   17 
Month 12 scan not available                15                15 
Baseline scan not analyzable                0                2 

Period 6:   Bone Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   110   101 
COMPLETED   104   85 
NOT COMPLETED   6   16 
Month 12 scan not available                6                16 

Period 7:   Cognitive Function Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   247   246 
COMPLETED   247   245 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 

Period 8:   Anemia Trial
    AndroGel® (Testosterone Gel)   Placebo Gel
STARTED   27   35 
COMPLETED   24   32 
NOT COMPLETED   3   3 
Withdrawal by Subject                3                3 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Two participants were randomized in error, one in each arm of the study.

Reporting Groups
  Description
AndroGel® (Testosterone Gel)

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo Gel

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Total Total of all reporting groups

Baseline Measures
   AndroGel® (Testosterone Gel)   Placebo Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 394   394   788 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
     
Main Testosterone Trial       
Participants Analyzed 
[Units: Participants]
 394   394   788 
Main Testosterone Trial   72.3  (5.8)   72.1  (5.7)   72.2  (5.8) 
Cardiovascular Trial       
Participants Analyzed 
[Units: Participants]
 73   65   138 
Cardiovascular Trial   70.5  (5.7)   72.0  (5.7)   71.2  (5.7) 
Bone Trial       
Participants Analyzed 
[Units: Participants]
 110   101   211 
Bone Trial   72.3  (6.3)   72.4  (5.5)   72.4  (5.9) 
Cognitive Function Trial       
Participants Analyzed 
[Units: Participants]
 247   246   493 
Cognitive Function Trial   72.3  (5.8)   72.8  (6.1)   72.6  (5.9) 
Anemia Trial       
Participants Analyzed 
[Units: Participants]
 27   35   62 
Anemia Trial   74.8  (6.0)   75.6  (7.5)   75.2  (6.8) 
[1] Men in the trial were 65 years of age or older.
[2] The number analyzed differs from the number randomized because 2 participants were randomized in error. Participants in the Sexual Function, Physical Function and Vitality trials are enrolled in the overall Main Testosterone Trial.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 394   394   788 
Female      0   0.0%      0   0.0%      0   0.0% 
Male      394 100.0%      394 100.0%      788 100.0% 
[1] All of the participants in this trial of testosterone gel use are men.
[2] The number of participants analyzed differs from the number randomized because some participants withdrew from the trial before month 12 or did not provide complete follow-up data.
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 394   394   788 
Hispanic or Latino      18   4.6%      10   2.5%      28   3.6% 
Not Hispanic or Latino      375  95.2%      384  97.5%      759  96.3% 
Unknown or Not Reported      1   0.3%      0   0.0%      1   0.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
Participants Analyzed 
[Units: Participants]
 394   394   788 
Caucasian      348  88.3%      350  88.8%      698  88.6% 
African-American      21   5.3%      20   5.1%      41   5.2% 
Other      25   6.3%      24   6.1%      49   6.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

2.  Primary:   Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)   [ Time Frame: 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12) ]

3.  Primary:   Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)   [ Time Frame: 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12) ]

4.  Primary:   Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume   [ Time Frame: 1 year (change in plaque volume measurement from baseline to month 12) ]

5.  Primary:   Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone   [ Time Frame: 1 year (QCT measurement of BMD change between baseline and month 12) ]

6.  Primary:   Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)   [ Time Frame: 1 year (change from baseline to month 6 and month 12) ]

7.  Primary:   Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia   [ Time Frame: 1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12) ]

8.  Secondary:   Sexual Function Trial - Sexual Desire Domain   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

9.  Secondary:   Sexual Function Trial - Erectile Function   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

10.  Secondary:   Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

11.  Secondary:   Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

12.  Secondary:   Physical Function Trial - PF 10 Overall Score   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

13.  Secondary:   Vitality Trial - FACIT Fatigue Overall Score   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

14.  Secondary:   Vitality Trial - SF-36 Score   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

15.  Secondary:   Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

16.  Secondary:   Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

17.  Secondary:   Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score   [ Time Frame: 1 year (change from baseline to month 3, 6, 9 and 12) ]

18.  Secondary:   Cardiovascular Trial - Total Plaque Volume Change From Baseline   [ Time Frame: 1 year (change from baseline to month 12) ]

19.  Secondary:   Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline   [ Time Frame: 1 year (change from baseline to month 12) ]

20.  Secondary:   Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)   [ Time Frame: 1 year (baseline to month 12) ]

21.  Secondary:   Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)   [ Time Frame: 1 year (baseline to month 12) ]

22.  Secondary:   Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)   [ Time Frame: 1 year (baseline to month 12) ]

23.  Secondary:   Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)   [ Time Frame: 1 year (baseline to month 12) ]

24.  Secondary:   Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)   [ Time Frame: 1 year (baseline to month 12) ]

25.  Secondary:   Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N   [ Time Frame: 1 year (baseline to month 12) ]

26.  Secondary:   Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N   [ Time Frame: 1 year (baseline to month 12) ]

27.  Secondary:   Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N   [ Time Frame: 1 year (baseline to month 12) ]

28.  Secondary:   Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N   [ Time Frame: 1 year (baseline to month 12) ]

29.  Secondary:   Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N   [ Time Frame: 1 year (baseline to month 12) ]

30.  Secondary:   Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N   [ Time Frame: 1 year (baseline to month 12) ]

31.  Secondary:   Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)   [ Time Frame: 1 year (baseline to month 12) ]

32.  Secondary:   Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)   [ Time Frame: 1 year (baseline to month 12) ]

33.  Secondary:   Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)   [ Time Frame: 1 year (baseline to month 12) ]

34.  Secondary:   Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)   [ Time Frame: 1 year (baseline to month 6 and month 12) ]

35.  Secondary:   Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)   [ Time Frame: 1 year (baseline to month 6 to month 12) ]

36.  Secondary:   Cognitive Function Trial - Executive Function - Trail Making Test B - A   [ Time Frame: 1 year (baseline to month 6 to month 12) ]

37.  Secondary:   Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)   [ Time Frame: 1 year (baseline to month 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: Peter J. Snyder, MD
Organization: University of Pennsylvania, Perelman School of Medicine
phone: 215-898-0208
e-mail: pjsnyder@upenn.edu


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


Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00799617     History of Changes
Other Study ID Numbers: U01AG030644 ( U.S. NIH Grant/Contract )
R01AG037679 ( U.S. NIH Grant/Contract )
First Submitted: November 26, 2008
First Posted: December 1, 2008
Results First Submitted: January 3, 2017
Results First Posted: August 28, 2017
Last Update Posted: October 12, 2017