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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
Sponsor:
Collaborator:
Fovea
Information provided by (Responsible Party):
Abbott

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

Condition or disease Intervention/treatment
Hypogonadism Drug: AndroGel (testosterone gel) 1%

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.

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Study Type : Observational
Actual Enrollment : 1053 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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.
Other Names:
  • Topical AndroGel
  • 1% AndroGel
  • AndroGel®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community
Criteria

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

Information from the National Library of Medicine

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


  Show 331 Study Locations
Sponsors and Collaborators
Abbott
Fovea
Investigators
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Study Director: Michael Miller, PharmD Abbott

Additional Information:
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01143818     History of Changes
Other Study ID Numbers: S176.4.103
First Posted: June 14, 2010    Key Record Dates
Results First Posted: September 26, 2011
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Abbott:
Male hypogonadism

Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents