ESPRIT Study in Hypogonadal Men

Study Overview
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Brief Summary
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Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.

Detailed Description
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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.

Official Title
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Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: AndroGel (testosterone gel) 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male patients >= 18 years of age Hypogonadism not previously treated with testosterone Testosterone deficiency confirmed clinically and biochemically Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics Exclusion Criteria According to the contra-indications, Unwilling or unable to sign informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AndroGel (testosterone gel )1%<br>AndroGel is topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. | Drug: AndroGel (testosterone gel) 1%<br>* AndroGel is topical testosterone gel 1% and is prescribed for once daily use.<br>* Other names: AndroGel®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to Month 6 | 
| 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. | Baseline to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male hypogonadism