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

NCT00196339 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2016-07-22

No results posted yet for this study

Summary

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.

Conditions

Interventions

DRUG

Cyproterone acetate 5

Cyproterone acetate 5 mg

DRUG

Placebo

Matching placebo

DRUG

Cyproterone acetate 15

Cyproterone acetate 15 mg

DRUG

Cyproterone acetate 25

Cyproterone acetate 25 mg

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Duramed Protocol Chair · Duramed Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196339 on ClinicalTrials.gov