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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196339

Enrollment

315

Registered

2005-09-20

Start date

2005-06-30

Completion date

2008-01-31

Last updated

2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, hot flashes, hot flushes, vasomotor symptoms

Brief 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.

Detailed 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.

Interventions

DRUGCyproterone acetate 5

Cyproterone acetate 5 mg

DRUGPlacebo

Matching placebo

DRUGCyproterone acetate 15

Cyproterone acetate 15 mg

DRUGCyproterone acetate 25

Cyproterone acetate 25 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety compared to placebo	Throughout study
Identify the lowest effective dose.	End of study
To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes	Throughout study

Secondary

Measure	Time frame
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026