Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
The objective of this study was to evaluate the efficacy and safety of AndroGel (testosterone gel) 1% following administration in community dwelling men with hypogonadism. The percent change from baseline to Month 6 in aging male symptom (AMS) assessment was the primary endpoint. Secondary endpoints were changes from baseline to Month 6 in International Index of Erectile Dysfunction (IIEF), Multidimensional Fatigue Inventory (MFI), and body mass index (BMI) assessments.
Study Type
OBSERVATIONAL
Enrollment
1,053
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
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
Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score
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
Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Ref # / Investigator 59749
Burnaby, British Columbia, Canada
Site Ref # / Investigator 59765
Coquitlam, British Columbia, Canada
Site Ref # / Investigator 59742
Kamloops, British Columbia, Canada
Site Ref # / Investigator 59775
Kelowna, British Columbia, Canada
Site Ref # / Investigator 59757
Penticton, British Columbia, Canada
Site Ref # / Investigator 59754
Victoria, British Columbia, Canada
Site Ref # / Investigator 59763
Winnipeg, Manitoba, Canada
Site Ref # / Investigator 59762
Winnipeg, Manitoba, Canada
Site Ref # / Investigator 59748
Dartmouth, Nova Scotia, Canada
Site Ref # / Investigator 59755
Halifax, Nova Scotia, Canada
...and 321 more locations
Percent Change From Baseline to Month 6 in Body Mass Index (BMI)
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