N/A
Completed N=1,049
ESPRIT Study in Hypogonadal Men
Source: ClinicalTrials.gov NCT01143818 ↗Enrolled (actual)
1,049
Serious AEs
0.3%
Results posted
Sep 2011
Primary outcomePrimary: Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score — -29.0 Percent Change
Summary
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score |
-29.0 | — |
| SECONDARY Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score |
115.7 | — |
| SECONDARY Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score |
-21.5 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Body Mass Index (BMI) |
-2.38 | — |
Eligibility Criteria
Inclusion Criteria
- Male patients >= 18 years of age
- Hypogonadism not previously treated with testosterone
- Testosterone deficiency confirmed clinically and biochemically
- Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics
Exclusion Criteria
- According to the contra-indications,
- Unwilling or unable to sign informed consent form
Data sourced from ClinicalTrials.gov (NCT01143818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.