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

D

Duramed Research

Status and phase

Completed
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Cyproterone acetate 15
Drug: Placebo
Drug: Cyproterone acetate 25
Drug: Cyproterone acetate 5

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196339
DR-PCA-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment

315 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  • Liver or kidney dysfunction
  • History or presence of cancer other than prostate cancer within the last 5 years
  • Surgery within the last 3 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

315 participants in 4 patient groups, including a placebo group

Cyproterone acetate 5 mg ( DR-2031)
Experimental group
Description:
1 tablet daily
Treatment:
Drug: Cyproterone acetate 5
Cyproterone acetate 15 mg ( DR-2031)
Experimental group
Description:
1 tablet daily
Treatment:
Drug: Cyproterone acetate 15
Cyproterone acetate 25 mg ( DR-2031)
Experimental group
Description:
1 tablet daily
Treatment:
Drug: Cyproterone acetate 25
Placebo
Placebo Comparator group
Description:
1 tablet daily
Treatment:
Drug: Placebo

Trial contacts and locations

118

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Data sourced from clinicaltrials.gov

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