Trial Condition(s):

Prostate Cancer

Androcur Non-interventional study among patients with carcinoma of the prostate (ANES)

Bayer Identifier:

14556

ClinicalTrials.gov Identifier:

NCT00919022

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective treatment of inoperable carcinoma of the prostate.

Sexual functions remain very important in men with prostate cancer. However sexual functions are deteriorating fast with course of the disease. The influence of CPA on sexual functions remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used validated simple scoring system for diagnosing of erectile dysfunction and belongs to most used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5 scored erectile dysfunction within the use of its indication in prostate cancer.

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.

Trial Summary

Enrollment Goal
194
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Androcur (Cyproterone Acetate, BAY94-8367)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Czech Republic

Status
Terminated
 

Trial Design