stop_circleTerminated/Withdrawn
Prostate Cancer
Bayer Identifier:
14556
ClinicalTrials.gov Identifier:
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.
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
194Trial Dates
August 2009 - August 2011Phase
N/ACould I Receive a placebo
NoProducts
Androcur (Cyproterone Acetate, BAY94-8367)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Correlation of PSA level and erectile dysfunctiondate_rangeTime Frame:6 monthsenhanced_encryptionNoSafety Issue:
- Sexual activity of Czech patients with inoperable prostate cancerdate_rangeTime Frame:6 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A