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
|Condition or disease||Intervention/treatment|
|Hypogonadism||Drug: AndroGel (testosterone gel) 1%|
|Study Type :||Observational|
|Actual Enrollment :||1053 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
AndroGel (testosterone gel )1%
AndroGel is topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose.
Drug: AndroGel (testosterone gel) 1%
AndroGel is topical testosterone gel 1% and is prescribed for once daily use.
- Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score [ Time Frame: Baseline to Month 6 ]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.
- Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score [ Time Frame: Baseline to Month 6 ]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.
- Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score [ Time Frame: Baseline to Month 6 ]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.
- Percent Change From Baseline to Month 6 in Body Mass Index (BMI) [ Time Frame: Baseline to Month 6 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143818
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|Study Director:||Michael Miller, PharmD||Abbott|