Recent Updates
Recently added Catalysts

Cyproterone 5

Phase 2

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

Cyproterone 5 target and mechanism

ModalitySmall molecule

Also known as Cyproterone acetate 5

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment315

FDA Designations

No designations recorded

Cyproterone 5 clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Prostate Cancer 417 trials

Top 20 of 55 competitors

Unlock Competitive Intelligence

Frequently asked questions about Cyproterone 5

What is Cyproterone 5?

Cyproterone 5 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It has been studied in a Phase 2 clinical trial for prostate cancer, specifically to treat hot flashes in prostate cancer patients. It is not yet approved and remains in clinical development.

What is Cyproterone 5 used for?

Cyproterone 5 is being studied for the treatment of hot flashes in prostate cancer patients. The only clinical trial of this drug was conducted in men with prostate cancer. It is an investigational therapy and has not been approved for any indication.

Who makes Cyproterone 5?

Cyproterone 5 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is the sponsor of the clinical trial evaluating this drug in prostate cancer patients.

What phase is Cyproterone 5 in?

Cyproterone 5 is in Phase 2 clinical development. The single trial for this drug was a Phase 2 study that has been completed. The drug is investigational and has not received FDA approval.

What clinical trials is Cyproterone 5 in?

Cyproterone 5 has been evaluated in one clinical trial, NCT00196339, titled "A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients." This completed Phase 2 trial enrolled 315 male participants across the United States and Canada.

Is Cyproterone 5 the same as Cyproterone acetate 5?

Yes, Cyproterone 5 is also known as Cyproterone acetate 5. Both names refer to the same investigational drug developed by Teva Pharmaceutical Industries Limited for prostate cancer.