drugset / Trial / NCT00555087
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The main objective of this study is to evaluate the response of erectile dysfunction in hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment. Secondary Study Objectives * To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid profile, renal-hepatic profile and glycemia, and control by means of a rectal digital examination. * To Determinate physiologic reconstitution in patients under treatment by means of total and free testosterone dosage.
Timeline
- Start
- 2007-05
- Primary completion
- —
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone Undecanoate | Small molecule | 1000 mg | Intramuscular |
| Background | Vardenafil | Small molecule | 20 mg | — |