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Cyproterone 5

Phase 2

Prostate Cancer | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Jul 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment315

FDA Designations

No designations recorded

Clinical trial landscape

Cyproterone 5 · 1 trial · 1 indication

Phase 2 1
NCT00196339A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer PatientsProstate Cancer
COMPLETED315 Analytics
PHASE2COMPLETED
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
Throughout study
To evaluate the safety compared to placebo
Throughout study
Identify the lowest effective dose.
End of study

Secondary Endpoints

To compare the efficacy in reducing the severity of all hot flashes
Throughout study
To compare the efficacy in elimination of all hot flashes
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cyproterone acetate 5 mg ( DR-2031)EXPERIMENTAL1 tablet daily
Cyproterone acetate 15 mg ( DR-2031)EXPERIMENTAL1 tablet daily
Cyproterone acetate 25 mg ( DR-2031)EXPERIMENTAL1 tablet daily
PlaceboPLACEBO_COMPARATOR1 tablet daily

Interventions

NameTypeDescription
Cyproterone acetate 5DRUGCyproterone acetate 5 mg
PlaceboDRUGMatching placebo
Cyproterone acetate 15DRUGCyproterone acetate 15 mg
Cyproterone acetate 25DRUGCyproterone acetate 25 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites118

Inclusion Criteria: * Prostate cancer patients who have undergone chemical or surgical castration * History of hot flashes for at least 30 days * Stable prostate cancer therapy for at least 45 days Exclusion Criteria: * Uncontrolled diabetes or severe COPD * History of thromboembolic disease * Li...

Countries:United StatesCanada
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Cyproterone 5

What is Cyproterone 5 used for?

Cyproterone 5 is an investigational small molecule being studied for the treatment of prostate cancer. It is currently in Phase 2 clinical development. The drug is being evaluated for its potential to manage symptoms associated with prostate cancer, specifically hot flashes, in patients undergoing treatment.

Who makes Cyproterone 5?

Cyproterone 5 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is currently in Phase 2 clinical development for the treatment of prostate cancer.

What phase is Cyproterone 5 in?

Cyproterone 5 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of prostate cancer, with one completed Phase 2 clinical trial.

What clinical trials is Cyproterone 5 in?

Cyproterone 5 has been studied in one clinical trial, identified as NCT00196339. This was a Phase 2, randomized, double-blind, placebo-controlled trial that evaluated the drug for the treatment of hot flashes in prostate cancer patients. The trial was completed and enrolled 315 participants in the United States and Canada.

Is Cyproterone 5 the same as DR-2031?

Yes, Cyproterone 5 is also known as DR-2031. The clinical trial NCT00196339, which studied the drug for hot flashes in prostate cancer patients, refers to the investigational agent as DR-2031. Both names refer to the same drug candidate.