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ESPRIT Study in Hypogonadal Men

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ClinicalTrials.gov Identifier: NCT01143818
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : September 26, 2011
Last Update Posted : October 17, 2011
Sponsor:
Collaborator:
Fovea
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Ecologic or Community;   Time Perspective: Prospective
Condition Hypogonadism
Intervention Drug: AndroGel (testosterone gel) 1%
Enrollment 1053
Recruitment Details Participants enrolled in this study were newly-diagnosed for hypogonadism and treatment naive to testosterone preparations. A total of 1053 participants were enrolled but only 1049 were treated with AndroGel.
Pre-assignment Details AndroGel (testosterone gel) 1% was prescribed according to the regional Summary of Product Characteristics with a starting dose of 50 mg testosterone/day (packaged as 1 sachet of 50 mg). Testosterone was applied once daily.
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
Period Title: Overall Study
Started 1049 [1]
Completed 799
Not Completed 250
[1]
A total of 1053 participants were enrolled but only 1049 received study drug.
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
Overall Number of Baseline Participants 1049
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1049 participants
53  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1049 participants
Female
0
   0.0%
Male
1049
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1049 participants
Canada 338
Russian Federation 267
Croatia 134
Germany 91
Slovenia 87
Saudi Arabia 68
Romania 54
United Arab Emirates 10
1.Primary Outcome
Title Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score
Hide Description The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants in the safety analysis set who had an Aging Male Symptoms (AMS) score available at baseline and Month 6.
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description:
Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
Overall Number of Participants Analyzed 712
Mean (Standard Deviation)
Unit of Measure: Percent Change
-29.0  (22.6)
2.Secondary Outcome
Title Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score
Hide Description The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6.
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description:
Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
Overall Number of Participants Analyzed 651
Mean (Standard Deviation)
Unit of Measure: Percent Change
115.7  (226.3)
3.Secondary Outcome
Title Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score
Hide Description The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6.
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description:
Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
Overall Number of Participants Analyzed 655
Mean (Standard Deviation)
Unit of Measure: Percent Change
-21.5  (33.5)
4.Secondary Outcome
Title Percent Change From Baseline to Month 6 in Body Mass Index (BMI)
Hide Description The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6.
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description:
Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
Overall Number of Participants Analyzed 611
Mean (Standard Deviation)
Unit of Measure: Percent Change
-2.38  (5.75)
Time Frame All reported adverse events are treatment-emergent and are defined as events that started or worsened at or after the first administration of AndroGel and ended before or at treatment completion. Only suspected adverse drug reactions were collected.
Adverse Event Reporting Description Treatment-emergent adverse events that were not serious occurred in 64 patients. None of the adverse events occured at a frequency threshold of >=5%. Therefore, no adverse events were reported.
 
Arm/Group Title AndroGel (Testosterone Gel) 1%
Hide Arm/Group Description Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
All-Cause Mortality
AndroGel (Testosterone Gel) 1%
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AndroGel (Testosterone Gel) 1%
Affected / at Risk (%)
Total   3/1049 (0.29%) 
Cardiac disorders   
Angina pectoris  1/1049 (0.10%) 
Atrial fibrillation  1/1049 (0.10%) 
Gastrointestinal disorders   
Nausea  1/1049 (0.10%) 
Vascular disorders   
Hypertension  1/1049 (0.10%) 
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AndroGel (Testosterone Gel) 1%
Affected / at Risk (%)
Total   0/1049 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01143818     History of Changes
Other Study ID Numbers: S176.4.103
First Submitted: June 9, 2010
First Posted: June 14, 2010
Results First Submitted: August 19, 2011
Results First Posted: September 26, 2011
Last Update Posted: October 17, 2011