stop_circleTerminated/Withdrawn

Prostate Cancer

Bayer Identifier:

14556

ClinicalTrials.gov Identifier:

NCT00919022

EudraCT Number:

Not Available

EU CT Number:

Not Available
Androcur Non-interventional study among patients with carcinoma of the prostate

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

  • - Males > 18 years previously untreated with Androcur.
    - No contraindication to Androcur.

  • - 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
August 2009 - August 2011
Phase
N/A
Could I Receive a placebo
No
Products
Androcur (Cyproterone Acetate, BAY94-8367)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Many Locations, Czech Republic

Primary Outcome

  • Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Correlation of PSA level and erectile dysfunction
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    No
  • Sexual activity of Czech patients with inoperable prostate cancer
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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