Trial Outcomes & Findings for ESPRIT Study in Hypogonadal Men (NCT NCT01143818)

NCT ID: NCT01143818

Last Updated: 2011-10-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1053 participants
• Primary outcome timeframe: Baseline to Month 6
• Results posted on: 2011-10-17

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	1049
Overall Study COMPLETED	799
Overall Study NOT COMPLETED	250

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ESPRIT Study in Hypogonadal Men

Baseline characteristics by cohort

Measure	AndroGel (Testosterone Gel) 1% n=1049 Participants 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.
Age Continuous	53 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1049 Participants n=5 Participants
Region of Enrollment Canada	338 Participants n=5 Participants
Region of Enrollment Russian Federation	267 Participants n=5 Participants
Region of Enrollment Croatia	134 Participants n=5 Participants
Region of Enrollment Germany	91 Participants n=5 Participants
Region of Enrollment Slovenia	87 Participants n=5 Participants
Region of Enrollment Saudi Arabia	68 Participants n=5 Participants
Region of Enrollment Romania	54 Participants n=5 Participants
Region of Enrollment United Arab Emirates	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AndroGel (Testosterone Gel) 1% n=712 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	AndroGel (Testosterone Gel) 1% n=651 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	AndroGel (Testosterone Gel) 1% n=655 Participants 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.
Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score	-21.5 Percent Change Standard Deviation 33.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AndroGel (Testosterone Gel) 1% n=611 Participants 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.
Percent Change From Baseline to Month 6 in Body Mass Index (BMI)	-2.38 Percent Change Standard Deviation 5.75

Adverse Events

AndroGel (Testosterone Gel) 1%

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	AndroGel (Testosterone Gel) 1% n=1049 participants at risk 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.
Cardiac disorders Angina pectoris	0.10% 1/1049 • 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. 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.
Cardiac disorders Atrial fibrillation	0.10% 1/1049 • 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. 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.
Vascular disorders Hypertension	0.10% 1/1049 • 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. 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.
Gastrointestinal disorders Nausea	0.10% 1/1049 • 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. 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.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
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