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Trial record 7 of 264 for:    Estrogen Resistance

Metabolic Effects of Androgenicity in Aging Men and Women

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.
 
ClinicalTrials.gov Identifier: NCT00680797
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : March 21, 2016
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Aging
Insulin Resistance
Interventions Drug: Testosterone
Drug: Estrogen
Enrollment 33
Recruitment Details 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  
Arm/Group Title +T +E +T -E -T +E -T -E
Hide Arm/Group Description

+Testosterone, +Estrogen

Testosterone: Testosterone gel

Estrogen: Estrogen patch

+Testosterone, -Estrogen

Testosterone: Testosterone gel

-Testosterone, +Estrogen

Estrogen: Estrogen patch

-Testosterone, -Estrogen
Period Title: Overall Study
Started 9 8 8 8
Completed 9 8 8 8
Not Completed 0 0 0 0
Arm/Group Title +T +E +T -E -T +E -T -E Total
Hide Arm/Group Description

+Testosterone, +Estrogen

Testosterone: Testosterone gel

Estrogen: Estrogen patch

+Testosterone, -Estrogen

Testosterone: Testosterone gel

-Testosterone, +Estrogen

Estrogen: Estrogen patch

-Testosterone, -Estrogen Total of all reporting groups
Overall Number of Baseline Participants 9 8 8 8 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 8 participants 8 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  55.6%
3
  37.5%
2
  25.0%
4
  50.0%
14
  42.4%
>=65 years
4
  44.4%
5
  62.5%
6
  75.0%
4
  50.0%
19
  57.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 8 participants 8 participants 33 participants
67  (8) 66  (5) 69  (6) 63  (3) 66  (6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 9 participants 8 participants 8 participants 8 participants 33 participants
9 8 8 8 33
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 8 participants 8 participants 8 participants 33 participants
9 8 8 8 33
Body-Mass-Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram/meter squared
Number Analyzed 9 participants 8 participants 8 participants 8 participants 33 participants
27.1  (4.9) 28.6  (4.3) 28.2  (4.1) 29.0  (2.9) 28.2  (4)
Total testosterone  
Mean (Standard Deviation)
Unit of measure:  Nanogram/deciliter
Number Analyzed 9 participants 8 participants 8 participants 8 participants 33 participants
419.6  (146.5) 418.9  (207.7) 480.0  (231.7) 558.3  (362.9) 467.7  (242)
1.Primary Outcome
Title Insulin Sensitivity
Hide Description As measured by change in insulin levels pre- and post-hormone changes
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants had missing values post-intervention therefore number of participants analyzed total 31.
Arm/Group Title +T +E +T -E -T +E -T -E
Hide Arm/Group Description:

+Testosterone, +Estrogen

Testosterone: Testosterone gel

Estrogen: Estrogen patch

+Testosterone, -Estrogen

Testosterone: Testosterone gel

-Testosterone, +Estrogen

Estrogen: Estrogen patch

-Testosterone, -Estrogen
Overall Number of Participants Analyzed 8 8 8 7
Mean (Standard Deviation)
Unit of Measure: micro International Units/mL
-0.16  (10.8) 2.62  (5.47) -0.50  (2.54) 1.83  (4.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection -T +E, -T -E
Comments The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection +T +E, -T +E
Comments The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments Comparison in the change in insulin levels between the groups receiving E with or without T.
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title +T +E +T -E -T +E -T -E
Hide Arm/Group Description

+Testosterone, +Estrogen

Testosterone: Testosterone gel

Estrogen: Estrogen patch

+Testosterone, -Estrogen

Testosterone: Testosterone gel

-Testosterone, +Estrogen

Estrogen: Estrogen patch

-Testosterone, -Estrogen
All-Cause Mortality
+T +E +T -E -T +E -T -E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
+T +E +T -E -T +E -T -E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
+T +E +T -E -T +E -T -E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Small sample size may limit generalizability of these results. Follow-up studies are being conducted to further evaluate these results.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Cathy Lee
Organization: VA Greater Los Angeles
Phone: 310-478-3711 ext 42627
EMail: cathy.lee2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00680797     History of Changes
Other Study ID Numbers: ARCD-034-04F
First Submitted: May 8, 2008
First Posted: May 20, 2008
Results First Submitted: July 24, 2014
Results First Posted: March 21, 2016
Last Update Posted: June 15, 2017