ESPRIT Study in Hypogonadal Men

Abbott

Status: Completed

Conditions: Hypogonadism

Treatments: Drug: AndroGel (testosterone gel) 1%

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01143818

S176.4.103

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,053 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,053 participants in 1 patient group

AndroGel (testosterone gel )1%

Description:

AndroGel is topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose.

Treatment:

Drug: AndroGel (testosterone gel) 1%