Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate Cancer

Keywords

prostate cancerhot flasheshot flushesvasomotor symptoms

Outcome Measures

Primary Outcomes (3)

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 Outcomes (2)

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

Study Arms (4)

Cyproterone acetate 5 mg ( DR-2031)

EXPERIMENTAL

1 tablet daily

Drug: Cyproterone acetate 5

Cyproterone acetate 15 mg ( DR-2031)

EXPERIMENTAL

1 tablet daily

Drug: Cyproterone acetate 15

Cyproterone acetate 25 mg ( DR-2031)

EXPERIMENTAL

1 tablet daily

Drug: Cyproterone acetate 25

Interventions

Cyproterone acetate 5Drug

Cyproterone acetate 5 mg

Also known as: DR-2031

Cyproterone acetate 5 mg ( DR-2031)

PlaceboDrug

Matching placebo

Placebo

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Prostate cancer patients who have undergone chemical or surgical castration
History of hot flashes for at least 30 days

Sponsors & Collaborators

Duramed Research
Industrylead

Study Sites (118)

Duramed Investigational Site

Birmingham, Alabama, 35209, United States

Duramed Investigational Site

Birmingham, Alabama, 35234, United States

Duramed Investigational Site

Homewood, Alabama, 35209, United States

Duramed Investigational Site

Huntsville, Alabama, 35801, United States

Duramed Investigational Site

Phoenix, Arizona, 85013, United States

Duramed Investigational Site

Tucson, Arizona, 85712, United States

Duramed Investigational Site

Little Rock, Arkansas, 72211, United States

MeSH Terms

Conditions

Prostatic NeoplasmsHot Flashes

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Duramed Protocol Chair
Duramed Research, Inc.
STUDY CHAIR

Enrollment

315 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 2005

Date type not reported

This date has not been verified as actual or estimated.

A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (4)

Cyproterone acetate 5 mg ( DR-2031)

Cyproterone acetate 15 mg ( DR-2031)

Cyproterone acetate 25 mg ( DR-2031)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (118)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (4)

Cyproterone acetate 5 mg ( DR-2031)

Cyproterone acetate 15 mg ( DR-2031)

Cyproterone acetate 25 mg ( DR-2031)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (118)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations