Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Flushing

Hot Flashes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Cyproterone Acetate

Cyproterone

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Male

Cyproterone acetate 5

Placebo

Cyproterone acetate 15

Cyproterone acetate 25

Duramed Protocol Chair

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.

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 in patients with mild to moderate vasomotor symptoms (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. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly.

Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

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

A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients

Duramed Research

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients	NCT00196339	Prostate Cancer	Cyproterone ace... Placebo Cyproterone ace... Cyproterone ace...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients	NCT00196339	Prostate Cancer	Cyproterone ace... Placebo Cyproterone ace... Cyproterone ace...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for cyproterone acetate 5