NCT01143818

ESPRIT Study in Hypogonadal Men

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,053 (actual)
• Sponsor: Abbott · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	AndroGel (testosterone gel) 1%	AndroGel is topical testosterone gel 1% and is prescribed for once daily use.

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-14
• Last updated: 2011-10-17
• Results posted: 2011-09-26

Locations

331 sites across 9 countries: Canada, Croatia, Germany, Kuwait, Romania, Russia, Saudi Arabia, Slovenia, United Arab Emirates