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T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin (T-IR)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686828
First Posted: September 18, 2012
Last Update Posted: July 6, 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.
Information provided by (Responsible Party):
Katya Rubinow, University of Washington
Results First Submitted: February 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Insulin Resistance
Type 2 Diabetes Mellitus
Obesity
Androgen Deficiency
Metabolic Disease
Interventions: Drug: Acyline
Drug: Testosterone 1.62% gel
Drug: Letrozole
Drug: Placebo gel (for Testosterone 1.62% gel)
Drug: Placebo pill (for Letrozole)

  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 period: 06/01/13-11/30/2014 Location: University/Medical Center Flyers, newspaper ads, online postings

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
116 subjects were screened, 63 subjects didn't meet study inclusion/exclusion criteria or they withdrew consent prior to group assignment, and 3 subjects withdrew prior to the baseline visit.

Reporting Groups
  Description
Acyline & Placebo Gel & Placebo Pill

Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel

Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Acyline & Testosterone Gel 1.25g/d & Placebo Pill

Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks

Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Acyline & Testosterone Gel 5g/d & Placebo Pill

Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks

Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Acyline & Testosterone Gel & Letrozole

Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks

Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks


Participant Flow:   Overall Study
    Acyline & Placebo Gel & Placebo Pill   Acyline & Testosterone Gel 1.25g/d & Placebo Pill   Acyline & Testosterone Gel 5g/d & Placebo Pill   Acyline & Testosterone Gel & Letrozole
STARTED   13   14   13   13 
COMPLETED   12   13   12   13 
NOT COMPLETED   1   1   1   0 
Physician Decision                1                0                0                0 
New Job                0                1                0                0 
Weight Loss                0                0                1                0 



  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.
No text entered.

Reporting Groups
  Description
Acyline & Placebo Gel & Placebo Pill

Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel

Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Acyline & Testosterone Gel 1.25g/d & Placebo Pill

Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks

Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Acyline & Testosterone Gel 5g/d & Placebo Pill

Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks

Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Acyline & Testosterone Gel & Letrozole

Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks

Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)

Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks

Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks

Total Total of all reporting groups

Baseline Measures
   Acyline & Placebo Gel & Placebo Pill   Acyline & Testosterone Gel 1.25g/d & Placebo Pill   Acyline & Testosterone Gel 5g/d & Placebo Pill   Acyline & Testosterone Gel & Letrozole   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   14   13   13   53 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 37 
 (27 to 51) 
 35 
 (27 to 45) 
 42 
 (31 to 51) 
 34 
 (28 to 45) 
 36 
 (29 to 48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      13 100.0%      14 100.0%      13 100.0%      13 100.0%      53 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      1   7.7%      0   0.0%      0   0.0%      0   0.0%      1   1.9% 
Not Hispanic or Latino      9  69.2%      11  78.6%      11  84.6%      13 100.0%      44  83.0% 
Unknown or Not Reported      3  23.1%      3  21.4%      2  15.4%      0   0.0%      8  15.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      2  15.4%      0   0.0%      0   0.0%      0   0.0%      2   3.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   7.7%      2  14.3%      0   0.0%      2  15.4%      5   9.4% 
White      7  53.8%      8  57.1%      11  84.6%      11  84.6%      37  69.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      3  23.1%      4  28.6%      2  15.4%      0   0.0%      9  17.0% 
Region of Enrollment 
[Units: Participants]
         
United States   13   14   13   13   53 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 26  (4)   26  (4)   25  (2)   25  (4)   25  (3) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 82  (14)   81  (15)   78  (8)   82  (11)   81  (12) 
Fasting Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 97  (6)   97  (13)   101  (7)   98  (9)   98  (9) 
Percentage Body Fat 
[Units: %total body mass]
Mean (Standard Deviation)
 28  (7)   23  (6)   24  (4)   23  (7)   24  (6) 
Percentage Lean Mass 
[Units: %total body mass]
Mean (Standard Deviation)
 68  (7)   73  (5)   72  (4)   73  (7)   72  (6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin Sensitivity Quantified by Matsuda Index   [ Time Frame: 4 weeks ]

2.  Secondary:   Changes in Body Composition   [ Time Frame: 4 weeks ]

3.  Secondary:   Changes in Adipose Tissue Gene Expression   [ Time Frame: 4 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
No text entered.


  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. Katya Rubinow
Organization: University of Washington
phone: 206-7543-3470
e-mail: rubinow@uw.edu


Publications:


Responsible Party: Katya Rubinow, University of Washington
ClinicalTrials.gov Identifier: NCT01686828     History of Changes
Other Study ID Numbers: 43007
First Submitted: September 12, 2012
First Posted: September 18, 2012
Results First Submitted: February 16, 2017
Results First Posted: June 14, 2017
Last Update Posted: July 6, 2017