Hypogonadism
Conditions
Keywords
Male hypogonadism
Brief summary
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
Detailed description
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.
Interventions
DRUGAndroGel (testosterone gel) 1%
AndroGel is topical testosterone gel 1% and is prescribed for once daily use.
Sponsors
Fovea
Abbott
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male patients \>= 18 years of age 2. Hypogonadism not previously treated with testosterone 3. Testosterone deficiency confirmed clinically and biochemically 4. Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics
Exclusion criteria
1. According to the contra-indications, 2. Unwilling or unable to sign informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score | 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 | 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) | 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. |
Countries
Canada, Croatia, Germany, Kuwait, Romania, Russia, Saudi Arabia, Slovenia, United Arab Emirates
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| AndroGel (Testosterone Gel) 1% 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. | 1,049 |
| Total | 1,049 |
Baseline characteristics
| Characteristic | AndroGel (Testosterone Gel) 1% |
|---|---|
| Age Continuous | 53 years STANDARD_DEVIATION 12 |
| Region of Enrollment Canada | 338 Participants |
| Region of Enrollment Croatia | 134 Participants |
| Region of Enrollment Germany | 91 Participants |
| Region of Enrollment Romania | 54 Participants |
| Region of Enrollment Russian Federation | 267 Participants |
| Region of Enrollment Saudi Arabia | 68 Participants |
| Region of Enrollment Slovenia | 87 Participants |
| Region of Enrollment United Arab Emirates | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1049 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,049 |
| serious Total, serious adverse events | 3 / 1,049 |
Outcome results
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AndroGel (Testosterone Gel) 1% | Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score | -29.0 Percent Change | Standard Deviation 22.6 |
Secondary
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
Population: The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AndroGel (Testosterone Gel) 1% | Percent Change From Baseline to Month 6 in Body Mass Index (BMI) | -2.38 Percent Change | Standard Deviation 5.75 |
Secondary
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
Population: The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AndroGel (Testosterone Gel) 1% | Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score | 115.7 Percent Change | Standard Deviation 226.3 |
Secondary
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
Population: The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AndroGel (Testosterone Gel) 1% | Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score | -21.5 Percent Change | Standard Deviation 33.5 |