Trial Information
Prospective Observational Non-interventional Study of Correlation of Treatment With Androcur, Disease Stage, Testosterone Level, Age With Sexual Function and Erectile Dysfunction (Measured by IIEF-5 Validated Questionnaire)
Inclusion Criteria:
- Males > 18 years previously untreated with Androcur.
- No contraindication to Androcur.
Exclusion Criteria:
- Liver diseases, malignant liver tumours and wasting diseases (except for carcinoma of
the prostate). A history of or existing thrombosis or embolism. Severe chronic
depression. Hypersensitivity to cyproterone. Cyproterone acetate in previous
therapy.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Czech Republic: State Institute for Drug Control
Study ID:
14556
NCT ID:
NCT00919022
Start Date:
August 2009
Completion Date:
August 2011
Related Keywords:
- Prostate Cancer
- Inoperable Prostate Cancer
- Erectile Dysfunction
- Prostatic Neoplasms
- Erectile Dysfunction