Metabolic Effects of Androgenicity in Aging Men and Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00680797
First received: May 8, 2008
Last updated: February 19, 2016
Last verified: February 2016
Results First Received: July 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Aging
Insulin Resistance
Interventions: Drug: Testosterone
Drug: Estrogen

  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
Recruitment methods included flyers and advertisement in local newspapers. Healthy Veteran and community participants who responded to to advertisement were screened by telephone for exclusion criteria. If no exclusion criteria were reported, participants were scheduled for a screening history and physical.

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
+T +E

+Testosterone, +Estrogen

Testosterone: Testosterone gel

Estrogen: Estrogen patch

+T -E

+Testosterone, -Estrogen

Testosterone: Testosterone gel

-T +E

-Testosterone, +Estrogen

Estrogen: Estrogen patch

-T -E -Testosterone, -Estrogen

Participant Flow:   Overall Study
    +T +E     +T -E     -T +E     -T -E  
STARTED     9     8     8     8  
COMPLETED     9     8     8     8  
NOT COMPLETED     0     0     0     0  



  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
+T +E

+Testosterone, +Estrogen

Testosterone: Testosterone gel

Estrogen: Estrogen patch

+T -E

+Testosterone, -Estrogen

Testosterone: Testosterone gel

-T +E

-Testosterone, +Estrogen

Estrogen: Estrogen patch

-T -E -Testosterone, -Estrogen
Total Total of all reporting groups

Baseline Measures
    +T +E     +T -E     -T +E     -T -E     Total  
Number of Participants  
[units: participants]
  9     8     8     8     33  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     5     3     2     4     14  
>=65 years     4     5     6     4     19  
Age  
[units: years]
Mean (Standard Deviation)
  67  (8)     66  (5)     69  (6)     63  (3)     66  (6)  
Gender, Customized  
[units: participants]
         
Male     9     8     8     8     33  
Region of Enrollment  
[units: participants]
         
United States     9     8     8     8     33  
Body-Mass-Index  
[units: kilogram/meter squared]
Mean (Standard Deviation)
  27.1  (4.9)     28.6  (4.3)     28.2  (4.1)     29.0  (2.9)     28.2  (4)  
Total testosterone  
[units: nanogram/deciliter]
Mean (Standard Deviation)
  419.6  (146.5)     418.9  (207.7)     480.0  (231.7)     558.3  (362.9)     467.7  (242)  



  Outcome Measures

1.  Primary:   Insulin Sensitivity   [ Time Frame: 6 weeks ]


  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
Small sample size may limit generalizability of these results. Follow-up studies are being conducted to further evaluate these results.


  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: Dr. Cathy Lee
Organization: VA Greater Los Angeles
phone: 310-478-3711 ext 42627
e-mail: cathy.lee2@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00680797     History of Changes
Other Study ID Numbers: ARCD-034-04F
Study First Received: May 8, 2008
Results First Received: July 24, 2014
Last Updated: February 19, 2016
Health Authority: United States: Federal Government