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Androcur Non-interventional Study Among Patients With Carcinoma of the Prostate

NCT ID: NCT00919022

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Inoperable Prostate Cancer Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Cyproterone Acetate (Androcur, BAY94-8367)

Intervention Type DRUG

Patients in regular clinical practice receiving Androcur according to local drug information

Interventions

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Cyproterone Acetate (Androcur, BAY94-8367)

Patients in regular clinical practice receiving Androcur according to local drug information

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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AC0910CZ

Identifier Type: OTHER

Identifier Source: secondary_id

14556

Identifier Type: -

Identifier Source: org_study_id